Label: WET WIPES- phenoxyethanol swab
- NDC Code(s): 78936-002-01
- Packager: Hangzhou Caring Cleaning Commodity Co.,Ltd
- 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 17, 2020
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
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Warnings
For external use only. Flammable, keep product away from fire or flame.
Do not use over large areas of the body if you are allergic to any of the ingredients when using this product,avoid contact with eyes and face.If contact occurs,flush thoroughly with water.Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.
- Do not use
- STOP USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Inactive ingredients
- Directions
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
WET WIPES
phenoxyethanol swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78936-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 3 g in 100 g PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL 0.3 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID ACETATE (UNII: DSO12WL7AU) POLYSORBATE 20 (UNII: 7T1F30V5YH) CHAMOMILE (UNII: FGL3685T2X) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78936-002-01 100 g in 1 PAIL; Type 0: Not a Combination Product 06/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part347 06/18/2020 Labeler - Hangzhou Caring Cleaning Commodity Co.,Ltd (413905445) Registrant - Hangzhou Caring Cleaning Commodity Co.,Ltd (413905445) Establishment Name Address ID/FEI Business Operations Hangzhou Caring Cleaning Commodity Co.,Ltd 413905445 manufacture(78936-002)