Label: BEBESUP HAND SANITIZER(ETHANOL)- alcohol gel
- NDC Code(s): 75356-0001-1
- Packager: AJ Co., 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 October 27, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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 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.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BEBESUP HAND SANITIZER(ETHANOL)
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75356-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 155 mL in 250 mL Inactive Ingredients Ingredient Name Strength GRAPEFRUIT (UNII: O82C39RR8C) TROMETHAMINE (UNII: 023C2WHX2V) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75356-0001-1 250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/10/2020 Labeler - AJ Co., Ltd. (631079605) Registrant - AJ Co., Ltd. (631079605) Establishment Name Address ID/FEI Business Operations AJ Co., Ltd. 631079605 manufacture(75356-0001) , label(75356-0001) , pack(75356-0001)