SAFETY DATA SHEET
SECTION 1: Identification
1.1. Product identifier
Product name: APUREE Nailtific™ Pure⁶ Toenail Fungus Treatment Extra Strength Day & Night System Kit
Product type: OTC Topical Treatment Kit
Kit Components (2 Items):
1. Daytime Toenail Fungus Treatment Extra Strength Pen
2. Nighttime Antifungal Nail Renewal Pen
1.2. Relevant identified uses
Identified uses: Topical application for nail care and renewal. External use only.
1.3. Details of the supplier of the safety data sheet
Brand Distributor (US):
SAVILAND OFFICIAL INC
1226 North King St. #260, Wilmington, DE, US
Telephone: +86 19927542010
Manufacturer:
Guangzhou Meixi Biotechnology Co., Ltd.
3 of No.4, 2 Floor and 3 Floor of No.4, Qiyuan Avenue, Huadu District, Guangzhou, 510880, China
1.4. Emergency telephone number
Emergency contact: +86 19927542010
SECTION 2: Hazard(s) identification
2.1. Classification for Individual Kit Components
This section provides the hazard classification for each individual product within the kit. Formulated as consumer-safe OTC products in a stable natural oil base, both variants are classified as Non-Hazardous under US OSHA GHS and EU CLP standards for transport and general consumer use.
- 1. Daytime Toenail Fungus Treatment Extra Strength Pen: Not classified as hazardous.
- 2. Nighttime Antifungal Nail Renewal Pen: Not classified as hazardous.
2.2. Label elements (Applies to Both Formulas)
Hazard pictograms: None required.
Signal word: None required.
Hazard statements: No known significant effects or critical hazards under intended OTC use.
Precautionary statements: P102: Keep out of reach of children. For external use only. Avoid contact with eyes.
2.3. Other hazards
Neither formula contains PBT or vPvB substances. Both formulas are non-flammable.
SECTION 3: Composition/information on ingredients
This kit consists of 2 distinct formulas. The active ingredients are blended into a highly stable, nourishing inactive base consisting primarily of natural oils.
| INCI Name (Ingredient) | CAS No. | Concentration (%) |
|---|---|---|
| Active Ingredients | ||
| Undecylenic Acid | 112-38-9 | 25.0% |
| Tolnaftate | 2398-96-1 | 1.0% |
| Inactive Ingredients | ||
| Simmondsia Chinensis (Jojoba) Seed Oil | 90045-98-0 | 55.0 - 65.0% |
| Melaleuca Alternifolia (Tea Tree) Oil | 68647-73-4 | 1.0 - 5.0% |
| Origanum Vulgare (Oregano) Oil | 8007-11-2 | 1.0 - 3.0% |
| Eugenia Caryophyllus (Clove) Bud Oil | 8000-34-8 | < 2.0% |
| Cinnamomum Cassia (Cinnamon) Oil | 8015-91-6 | < 2.0% |
| Salicylic Acid | 69-72-7 | < 1.0% |
| Eucalyptus Globulus Leaf Oil | 8000-48-4 | < 1.0% |
| INCI Name (Ingredient) | CAS No. | Concentration (%) |
|---|---|---|
| Active Ingredients | ||
| Tolnaftate | 2398-96-1 | 1.0% |
| Inactive Ingredients | ||
| Simmondsia Chinensis (Jojoba) Seed Oil | 90045-98-0 | 80.0 - 90.0% |
| Melaleuca Alternifolia (Tea Tree) Oil | 68647-73-4 | 1.0 - 5.0% |
| Lavandula Angustifolia (Lavender) Oil | 8000-28-0 | 1.0 - 5.0% |
| Origanum Vulgare (Oregano) Oil | 8007-11-2 | 1.0 - 3.0% |
| Cinnamomum Cassia (Cinnamon) Oil | 8015-91-6 | < 2.0% |
| Eugenia Caryophyllus (Clove) Bud Oil | 8000-34-8 | < 2.0% |
| Eucalyptus Globulus Leaf Oil | 8000-48-4 | < 1.0% |
SECTION 4: First-aid measures
4.1. Description of first-aid measures
Eye Contact: Flush cautiously with water. Remove contact lenses if applicable. Non-corrosive, but natural oils may temporarily blur vision.
Skin Contact: Formulated for skin/nail application. If an unexpected reaction occurs, wash with soap and water.
Inhalation: Not applicable (non-volatile oil base).
Ingestion: Do not induce vomiting. Drink water to dilute.
SECTION 5: Fire-fighting measures
Suitable extinguishing media: CO2, dry chemical, foam. Do not use water jet.
Special hazards: Non-flammable under normal conditions. Both formulas are stable.
SECTION 6: Accidental release measures
Cleanup: Slipping hazard if spilled. Absorb with paper towel or cloth. Clean surface with soap and water.
SECTION 7: Handling and storage
Storage: Store both Daytime and Nighttime pens in a cool, dry place. Keep caps tightly closed when not in use.
SECTION 8: Exposure controls/personal protection
Personal protection: Not required for normal consumer use. Safe for direct topical contact as directed.
SECTION 9: Physical and chemical properties for Kit Components
The following physical and chemical properties apply to both the Daytime Pen and the Nighttime Pen:
- Appearance: Pale yellow to amber oily liquid
- Odor: Herbal / Botanical (Tea Tree, Oregano, Lavender)
- pH: Not applicable (Anhydrous/Oil-based formulations)
- Flash point (Closed Cup): > 150°C (Non-Flammable)
- Relative density: 0.90 - 0.98 g/cm³
- Solubility in water: Insoluble
- Volatility: Non-volatile
SECTION 10: Stability and reactivity
Stability: Both formulas are highly stable under normal ambient temperatures.
Incompatible materials: Strong oxidizing agents.
SECTION 11: Toxicological information for Kit Components
Toxicological assessment for 1. Daytime Formula and 2. Nighttime Formula:
- Acute toxicity: Low toxicity profile. Formulated for safe topical application.
- Skin corrosion/irritation: Non-corrosive. Actives are safely buffered within a rich Jojoba oil base.
- Serious eye damage/irritation: May cause mild temporary discomfort if accidentally rubbed into eyes, typical of natural essential oils.
- Sensitization: Extremely low risk under intended use. Free from aggressive industrial solvents.
SECTION 12: Ecological information
Biodegradability: The Jojoba oil base and natural essential oils are readily biodegradable in the environment.
SECTION 13: Disposal considerations
Dispose of in accordance with local regulations. Consumer-sized packaging can be disposed of in standard household waste.
SECTION 14: Transport information for Kit Components
The transport classification below applies equally to both the Daytime Formula and the Nighttime Formula:
Regulation Status: NOT REGULATED (Non-Dangerous Goods)
UN Number: N/A
UN proper shipping name: N/A (Consumer Commodity / OTC Drug)
Transport hazard class(es): N/A
Packing group: N/A
Logistics Compliance
Flash Point verification: > 150°C.
US DOT / IATA (Air) / IMDG (Sea): Not restricted for transport. Does not meet the criteria for flammable liquids or hazardous materials.
SECTION 15: Regulatory information for Kit Components
Regulatory compliance for both formulas in the kit:
United States (US):
- FDA: Formulations comply with FDA OTC Monograph requirements for topical application.
- TSCA: All ingredients are compliant or exempt.
- California Proposition 65: Contains no listed chemicals requiring a warning.
European Union (EU):
- EU CLP / REACH: Ingredients comply with relevant safety and registration thresholds.
SECTION 16: Other information
Disclaimer:
The information provided in this Safety Data Sheet is correct to the best of our knowledge at the date of its publication. It is designed only as a guidance for safe handling, use, processing, and transport of the 2-item kit described herein. This product is intended for external use only.