Label: WET WIPES patch
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Contains inactivated NDC Code(s)
NDC Code(s): 78055-010-01 - Packager: Dalian Oupai Technology 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 October 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS FOR USE:
- STORAGE AND HANDLING
- Inactive ingredients
- Purpose
- USES
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WARNING
Do not freeze.For external use only,Store at room temperature.
Do not use in ears,eyes or mouth.
Avoid contact with the eyes.In case of contact,flush eyes with water.
Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.
Keep out of reach of children.
Children should be supervised when using this product.
If swallowed, get medical help or contact Poison Control Centre immediately.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WET WIPES
wet wipes patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78055-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 g in 100 g WATER (UNII: 059QF0KO0R) 98.73 g in 100 g PROPANEDIOL (UNII: 5965N8W85T) 0.2 g in 100 g ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 g in 100 g BETAINE (UNII: 3SCV180C9W) 0.1 g in 100 g CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S) 0.05 g in 100 g CHLORPHENESIN (UNII: I670DAL4SZ) 0.05 g in 100 g .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.05 g in 100 g POLY(LAURYLGLUCOSIDE)-7 (UNII: VB00RDE21R) 0.05 g in 100 g CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.02 g in 100 g SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.02 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78055-010-01 70 in 1 PAIL 09/28/2020 1 6.5 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/28/2020 Labeler - Dalian Oupai Technology Co.,Ltd. (529342302) Establishment Name Address ID/FEI Business Operations Dalian Oupai Technology Co.,Ltd. 529342302 manufacture(78055-010)
