Label: HAND SANITIZER GEL WITH FRAGRANCE- isopropyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74664-007-01, 74664-007-02, 74664-007-03, 74664-007-04, view more74664-007-05, 74664-007-06, 74664-007-07, 74664-007-08 - Packager: Tri-Chem Industries
- 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 September 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 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).
- Triethanolamine.
- Propylene glycol.
- Acrylic copolymer or carbomer.
- Fragrance.
- Sterile distilled water or boiled cold water.
The formulation meets the required efficacy for the protection of human health from germs and viruses when used in the absence of water and soap.
- 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 GEL WITH FRAGRANCE
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74664-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H) TROLAMINE (UNII: 9O3K93S3TK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE (UNII: V5VD430YW9) GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.367 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74664-007-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/18/2020 2 NDC:74664-007-02 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/18/2020 3 NDC:74664-007-03 18900 mL in 1 PAIL; Type 0: Not a Combination Product 09/18/2020 4 NDC:74664-007-05 1041000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 09/18/2020 5 NDC:74664-007-06 1249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 09/18/2020 6 NDC:74664-007-07 24605000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 09/18/2020 7 NDC:74664-007-04 20800 mL in 1 DRUM; Type 0: Not a Combination Product 09/18/2020 8 NDC:74664-007-08 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/18/2020 Labeler - Tri-Chem Industries (798244414) Registrant - Tri-Chem Industries (798244414) Establishment Name Address ID/FEI Business Operations Tri-Chem Industries 798244414 manufacture(74664-007) , label(74664-007) , pack(74664-007) , repack(74664-007) , relabel(74664-007)