Label: HAND SANITIZER- benzalkonium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 75094-007-07, 75094-007-08 - Packager: Sell-Able 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 May 31, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- When using this product
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Other information
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Inactive ingredients
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLOXAMER 124 (UNII: 1S66E28KXA)
D&C GREEN NO. 8 (UNII: I2W85YOX9L) - Directions
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
benzalkonium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75094-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 12 g in 100 mL Inactive Ingredients Ingredient Name Strength DEHYDROACETIC ACID (UNII: 2KAG279R6R) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) D&C GREEN NO. 8 (UNII: I2W85YOX9L) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLOXAMER 124 (UNII: 1S66E28KXA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75094-007-07 15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/30/2020 2 NDC:75094-007-08 15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Sell-Able LLC (080963581)
