Label: FOAMFRESH ALCO-FREE HAND SANITIZER- benzalkonium chloride liquid
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NDC Code(s):
11429-1001-0,
11429-1001-2,
11429-1001-3,
11429-1001-4, view more11429-1001-7, 11429-1001-8, 11429-1001-9
- Packager: Woodbine Products Company
- Category: HUMAN OTC DRUG LABEL
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, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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PRINCIPAL DISPLAY PANEL
FoamFresh
Alco-Free Hand Sanitizer
Formulated to reduce the number of germs on the hands that can cause infection and illness
Alcohol free, so it can be used in any area without fear of it creating a flammable atmosphere
Use on clean, non-soiled hands any time when rinsing with water is not available
Kills 99.99% of common germs that can cause disease
PK
Woodbine Products Company
915 West Smith Road
Medina, Ohio 44256
wwww.woodbineproducts.com
Made in the U.S.A.
Stock # 4350 1000 ml (34 fl. oz.)
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INGREDIENTS AND APPEARANCE
FOAMFRESH ALCO-FREE HAND SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11429-1001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5) GLYCERETH-17 COCOATE (UNII: 3057VPT0KC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11429-1001-2 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2018 2 NDC:11429-1001-3 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2018 3 NDC:11429-1001-4 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2018 4 NDC:11429-1001-7 750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2018 5 NDC:11429-1001-8 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2018 6 NDC:11429-1001-9 1100 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/16/2014 7 NDC:11429-1001-0 1125 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/16/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/16/2014 Labeler - Woodbine Products Company (004220323) Establishment Name Address ID/FEI Business Operations Woodbine Products Company 004220323 manufacture(11429-1001)