Label: CLEAN SEPT ALCOHOL ANTISEPTIC 70% - TOPICAL HAND SANITIZER NON-STERILE GEL- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79916-001-01, 79916-001-02, 79916-001-03, 79916-001-04, view more79916-001-05 - Packager: BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA
- 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 December 7, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts Panel - Active Ingredients
- Drug Facts Panel - Purpose
- Drug Facts Panel - Use
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Drug Facts Panel - 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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - Drug Facts Panel - Directions
- Drug Facts Panel - Other Information
- Drug Facts Panel - Inactive Ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
CLEAN SEPT ALCOHOL ANTISEPTIC 70% - TOPICAL HAND SANITIZER NON-STERILE GEL
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79916-001 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 TROLAMINE (UNII: 9O3K93S3TK) 0.18 mL in 100 mL WATER (UNII: 059QF0KO0R) 28.22 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1 mL in 100 mL CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) 0.6 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79916-001-01 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/06/2020 2 NDC:79916-001-02 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/06/2020 3 NDC:79916-001-03 1500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/06/2020 4 NDC:79916-001-04 5000 mL in 1 JUG; Type 0: Not a Combination Product 08/06/2020 5 NDC:79916-001-05 3 mL in 1 POUCH; Type 0: Not a Combination Product 08/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/06/2020 Labeler - BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA (900786538) Establishment Name Address ID/FEI Business Operations BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA 900786538 manufacture(79916-001) , pack(79916-001) , label(79916-001)
