Label: STERILEMAX HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79325-870-50 - Packager: Pure-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 October 14, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient[s]
- Purpose
- Use[s]
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Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
• in children less than 2 months of age
• on open skin wounds
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. - Directions
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
LEMON FRESH
KILLS 99.99% OF GERMS*
70% ALCOHOL - REFRESHING GEL
*Effective at eliminating 9.99% of many common harmful germs and bacteria
STERILE MAX.COM
Dispose of contents/container in accordance with local/regional/national/international regulations.
See SDS for Additional Information.
Distributed by Pure-Chem LLC
Manufactured in St. Louis, MO - Packaging
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INGREDIENTS AND APPEARANCE
STERILEMAX HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79325-870 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 BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) BENZOPHENONE (UNII: 701M4TTV9O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) DIISOPROPYLAMINE (UNII: BR9JLI40NO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79325-870-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/14/2020 Labeler - Pure-chem, Llc (117559894)