Label: ADVANCED ALCOHOL FOAMING HAND SANITIZER- alcohol soap
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Contains inactivated NDC Code(s)
NDC Code(s): 65601-800-03, 65601-800-04, 65601-800-05, 65601-800-29, view more65601-800-53, 65601-800-55, 65601-800-57, 65601-800-88 - Packager: Betco Corporation, Ltd.
- 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 February 10, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Uses
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Warnings
Warnings
- For external use only. Do not ingest.
- FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition.
- Avoid contact with eyes. In case of eye contact, flush with large quantities of water, seek medical attention if irritation persists.
- If skin irritation develops, discontinue use. If irritation persists for more than 72 hours, seek medical attention.
- Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center right away
- Directions
- Inactive Ingredients
- Purpose
- Advanced Alcohol Foaming Hand Sanitizer
- Advanced Alcohol Foaming Hand Sanitizer
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INGREDIENTS AND APPEARANCE
ADVANCED ALCOHOL FOAMING HAND SANITIZER
alcohol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65601-800 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) TETRAHYDROLINALOOL (UNII: UM4XS5M134) ISOPROPYLPHENYLBUTANAL (UNII: Z92022479Y) EBANOL (UNII: 28N247O58B) ALOE VERA LEAF (UNII: ZY81Z83H0X) CYCLOMETHICONE 4 (UNII: CZ227117JE) BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4) 2-SEC-BUTYL CYCLOHEXANONE (UNII: 5WA6R1KL5J) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) TETRAHYDROLINALYL ACETATE (UNII: 2NDV3959AX) HEXYL ACETATE (UNII: 7U7KU3MWT0) Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65601-800-04 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:65601-800-53 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/30/2020 3 NDC:65601-800-57 550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/30/2020 4 NDC:65601-800-29 1000 mL in 1 BAG; Type 0: Not a Combination Product 03/30/2020 5 NDC:65601-800-03 750 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 6 NDC:65601-800-05 1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 09/11/2020 7 NDC:65601-800-88 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/30/2020 8 NDC:65601-800-55 208198 mL in 1 DRUM; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/30/2020 Labeler - Betco Corporation, Ltd. (024492831) Registrant - Betco Corporation, Ltd. (024492831) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd. 024492831 manufacture(65601-800) , label(65601-800)
