Label: EO HAND SANITIZER PEPPERMINT- alcohol spray
- NDC Code(s): 54748-102-01, 54748-102-02
- Packager: Small World Trading Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated December 22, 2012
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of childrenClose
- INDICATIONS & USAGE
Uses: For hand washing to decrease bacteria on skin. Recommended for repeated useClose
For external use only
Keep away from fire/flame
Do not use this product in or near eyes. if contact occurs, rinse thoroughly with water
Keep out of reach of children
Children under 6 years of age should be supervised when using this product.
- DOSAGE & ADMINISTRATION
Spray onto palm, Rub hands together.Close
- INACTIVE INGREDIENT
Purified Water, Organic Mentha Piperita (Peppermint) Oil, Organic Thymus Vulgaris (Thyme) Leaf Extract, Vegetable Glycerin, Tocopherol (Vitamin E).Close
- STORAGE AND HANDLING
Do not store above 104°F / 40°C, May discolor some fabrics.
- INGREDIENTS AND APPEARANCE
EO HAND SANITIZER PEPPERMINT
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54748-102 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PEPPERMINT OIL (UNII: AV092KU4JH) THYMUS VULGARIS LEAF (UNII: GRX3499643) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54748-102-01 10 mL in 1 BOTTLE, SPRAY 2 NDC:54748-102-02 60 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/15/2013 Labeler - Small World Trading Company (786611210) Establishment Name Address ID/FEI Business Operations Small World Trading Company 786611210 manufacture(54748-102)