Label: SANITEX ANTIBACTERIAL HAND WIPES CITRUS SCENT- benzalkonium chloride swab
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Contains inactivated NDC Code(s)
NDC Code(s): 53118-001-01, 53118-001-02 - Packager: PREMIER CARE INDUSTRIES, INC
- 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 18, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
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Directions
For 40 Count wipes:
- Take wipe and rub thoroughly over all surfaces of both hands.
- Rub hands together briskly to dry and allow to air dry.
- Dispose of wipe in trash.
- Do not flush.
For 20 Count wipes:
Adults and Children 2 Years and Over: Apply to hands and face. Allow to dry without wiping.
Children Under 2 Years: Ask a doctor before use.
- To Dispense:Peel back front label slowly. Remove Wipes.
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To Reseal: Firmly run thumb over the label. Dispose
of wipe in trash. Do not flush.
- Other Information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SANITEX ANTIBACTERIAL HAND WIPES CITRUS SCENT
benzalkonium chloride swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53118-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.26 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) 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:53118-001-01 40 in 1 CANISTER 1 3 g in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:53118-001-02 20 in 1 BAG 2 3 g in 1 POUCH; 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 06/18/2015 Labeler - PREMIER CARE INDUSTRIES, INC (858442403) Establishment Name Address ID/FEI Business Operations PREMIER CARE INDUSTRIES, INC 858442403 manufacture(53118-001)
