Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78391-001-01, 78391-001-02 - Packager: Kepter Mexico S.A de C.V
- 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 23, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:
a. Alcohol (ethanol) (USP of Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
b. Glycerin (.5% v/v).
c. Carbopol (.5% v/v).
d. Triethanolamine (.4% v/v).
e. Sterile distilled water or boiled cold water.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
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 doctor: If irritation, rash or redness ocurrs. These may be signs of a serious condition.
Keep out reach of children: If swallowed, get medical help or contat a Posion Control Center right away.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive Ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78391-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 28 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78391-001-01 976 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 2 NDC:78391-001-02 3786 mL in 1 BOTTLE; 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 - Kepter Mexico S.A de C.V (812889284) Establishment Name Address ID/FEI Business Operations Kepter Mexico S.A de C.V 812889284 manufacture(78391-001)
