Label: FROZEN FRESH SCENTED HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 54699-016-01 - Packager: Ouya Cosmetics Co., Ltd of Yiwu City
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 9, 2021
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- Active Ingredient
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
FROZEN FRESH SCENTED HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54699-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54699-016-01 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/09/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/09/2021 Labeler - Ouya Cosmetics Co., Ltd of Yiwu City (546464926)