Label: HAND SANITIZER 70% GEL SOLUTION- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74833-720-02, 74833-720-03, 74833-720-04, 74833-720-05, view more74833-720-06, 74833-720-07, 74833-720-08 - Packager: U.S. Oil Chem, 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 July 22, 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
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.
- Sterile Water
- Hydroxypropyl Cellulose
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
- 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 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. - 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 70% GEL SOLUTION
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74833-720 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 2649 mL in 3783 mL Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74833-720-03 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2020 2 NDC:74833-720-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2020 3 NDC:74833-720-04 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2020 4 NDC:74833-720-05 475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/12/2020 5 NDC:74833-720-06 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/12/2020 6 NDC:74833-720-08 3786 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/12/2020 7 NDC:74833-720-07 1893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/12/2020 Labeler - U.S. Oil Chem, LLC (080356315)