Label: LIFEBUOY HAND SANITIZER PROFESSIONAL- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50069-111-11, 50069-111-12, 50069-111-13, 50069-111-14, view more50069-111-15 - Packager: UNILEVER ASIA PRIVATE LIMITED
- This is a repackaged label.
- Source NDC Code(s): 73931-015
- 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 November 4, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
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WARNINGS
For External Use only. Highly flammable liquid and vapour. Keep away from/do not spray near heat, hot surfaces, sparks, electrical appliances, open flames and other ignition sources. Do not store in car. No smoking. Keep containers tightly closed.
Do Not Use
- On 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, rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
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
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIFEBUOY HAND SANITIZER PROFESSIONAL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50069-111(NDC:73931-015) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50069-111-11 5000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/25/2020 2 NDC:50069-111-13 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2020 3 NDC:50069-111-12 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2020 4 NDC:50069-111-14 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2020 5 NDC:50069-111-15 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/25/2020 Labeler - UNILEVER ASIA PRIVATE LIMITED (894632699)