Label: BIOPROTECT ALCOHOL FREE HAND SANITIZER- benzalkonium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 79141-001-00 - Packager: Global BioProtect, 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 August 19, 2020
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- DRUG FACTS
- Active Ingredient:
- Uses:
- Warnings:
- Directions:
- Inactive Ingredients:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
BIOPROTECT ALCOHOL FREE HAND SANITIZER
benzalkonium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79141-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET) C12-15 PARETH-12 (UNII: 131316X18L) CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79141-001-00 236 mL in 1 CAN; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/01/2020 Labeler - Global BioProtect, LLC (080387141) Establishment Name Address ID/FEI Business Operations Vin Mar Industries LLC 114772616 pack(79141-001) Establishment Name Address ID/FEI Business Operations BRENNTAG MID-SOUTH, INC. 122625064 manufacture(79141-001)