Label: SANITIZING WIPES- benzalkonium chloride swab
- NDC Code(s): 70972-1200-1
- Packager: Wipes LLC
- 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 November 29, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
Adults and Children 2 Years and Over: Apply to hands. Allow to dry without wiping.
Children under 2 Years: Ask a doctor before use
To dispense: Pull tab and remove large cover. Insert triangular threading loop through slits in cover. Do not push finger through the opening. Thread first sheet in center of roll through loop. Replace cover. Pull loop back through opening. Pull each sheet up and slightly to the side. Dispose of wipe in trash. DO NOT FLUSH.
- Other information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SANITIZING WIPES
benzalkonium chloride swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70972-1200 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 WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) EDETATE DISODIUM (UNII: 7FLD91C86K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70972-1200-1 1200 in 1 BAG 04/04/2017 1 0.00273 g in 1 PACKET; 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 04/04/2017 Labeler - Wipes LLC (964227347) Registrant - Precare Corp. (117111327) Establishment Name Address ID/FEI Business Operations Precare Corp. 117111327 manufacture(70972-1200)