Label: HAND SANITIZER- alcohol liquid
- NDC Code(s): 74260-001-01
- Packager: Star Union Spirits
- 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.
Updated December 30, 2021
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SPL UNCLASSIFIED SECTION
Star Union Spirits
Alcohol Antiseptic 80%
Antiseptic Hand Sanitizer
NOT FOR HUMAN CONSUMPTION
Produced in accordance with World Health Organization
These guidelines do not currently permit the use of a thickening agent.
NOT FOR RE-SALE
- Active Ingredient(s)
- Do not use
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
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74260-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74260-001-01 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 10/01/2021 Labeler - Star Union Spirits (116377204) Registrant - Star Union Spirits (116377204) Establishment Name Address ID/FEI Business Operations Star Union Spirits 116377204 manufacture(74260-001)