Label: SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT- benzalkonium chloride swab
- NDC Code(s): 53118-002-01, 53118-002-02, 53118-002-03
- Packager: Precare Corp
- 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
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
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: Peel back front label slowly. Remove wipes.
- To reseal: Firmly rub thumb over label.
Dispose of wipe in trash. Do not flush.
For single wipe sachet
- Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe.
- Rub hands together briskly to dry without wiping.
- Dispose of wipe
- Do not flush
- Other Information
- Inactive ingredients
-
Principal Display Panel
NDC 53118-002-01
Sanitex ®
Antibacterial
HAND WIPES
Kills 99.9% of Germs
Enriched with Aloe
FRESH SCENT
40 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm)
NDC 53118-002-02
Sanitex ®
Antibacterial
HAND WIPES
Kills 99.9% of Germs
Enriched with Aloe
FRESH SCENT
20 wipes| 6 inch x 7 inch (15.2 cm x 17.8 cm)
NDC 53118-002-03
Sanitex ®
Antibacterial
HAND WIPE
Kills 99.9% of Germs
Enriched with Aloe
FRESH SCENT
1 Wipe | 6 inch X 8 inch (15.2 cm X 20.3 cm)
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INGREDIENTS AND APPEARANCE
SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT
benzalkonium chloride swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53118-002 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) 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:53118-002-01 40 in 1 CANISTER 06/17/2015 1 3 g in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:53118-002-02 20 in 1 BAG 06/17/2015 2 3 g in 1 POUCH; Type 0: Not a Combination Product 3 NDC:53118-002-03 1 in 1 PACKAGE 07/10/2020 3 3 g in 1 PACKAGE; 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 06/17/2015 Labeler - Precare Corp (858442403) Registrant - Precare Corp (117111327) Establishment Name Address ID/FEI Business Operations Precare Corp 117111327 manufacture(53118-002)