Label: GENTLE BEAST ANTISEPTIC WIPES- isopropyl alcohol swab
- NDC Code(s): 75356-0008-1
- 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 March 16, 2021
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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 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.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GENTLE BEAST ANTISEPTIC WIPES
isopropyl alcohol swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75356-0008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 g in 100 g Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYSORBATE 20 (UNII: 7T1F30V5YH) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75356-0008-1 337 g in 1 PACKET; Type 0: Not a Combination Product 03/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/01/2021 Labeler - AJ Co., Ltd. (631079605) Registrant - AJ Co., Ltd. (631079605) Establishment Name Address ID/FEI Business Operations AJ Co., Ltd. 631079605 manufacture(75356-0008) , label(75356-0008) , pack(75356-0008)