Label: HAND SANITIZER- alcohol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 64596-382-30 - Packager: Gilchrist & Soames
- 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 8, 2020
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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:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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.
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - Directions
- 1 oz EtOH
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64596-382 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 77 g in 100 g Inactive Ingredients Ingredient Name Strength AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.1 g in 100 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 g in 100 g CARBOMER 980 (UNII: 4Q93RCW27E) 0.5 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 0.5 g in 100 g WATER (UNII: 059QF0KO0R) 25.4 g in 100 g ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.5 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64596-382-30 30 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 05/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/29/2020 Labeler - Gilchrist & Soames (052683856) Registrant - Gilchrist & Soames (052683856) Establishment Name Address ID/FEI Business Operations Gilchrist & Soames 052683856 manufacture(64596-382)
30mL NDC: 64596-382-30