GENTLE BEAST ANTISEPTIC WIPES- isopropyl alcohol swab 
AJ Co., Ltd.

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.

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AJ Co., Ltd. - Gentle Beast Antiseptic Wipes

Isopropyl Alcohol

Butylene Glycol, Cetylpyridinium chloride, Citric Acid, Glycerin, Polysorbate 20, Sodium Benzoate, Water

Decrease bacteria on skin. For use when soap and water are not available.

keep out of reach of the children

■ Discard after single use and do not flush in the toilet.

■ Reseal back after use to avoid evaporation of alcohol

■ Supervise children under 6 years of age when using this product to avoid swallowing.

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.

for external use only

1

GENTLE BEAST ANTISEPTIC WIPES 
isopropyl alcohol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75356-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75356-0008-1337 g in 1 PACKET; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/2021
Labeler - AJ Co., Ltd. (631079605)
Registrant - AJ Co., Ltd. (631079605)
Establishment
NameAddressID/FEIBusiness Operations
AJ Co., Ltd.631079605manufacture(75356-0008) , label(75356-0008) , pack(75356-0008)

Revised: 3/2021
Document Id: bdb36b01-f424-8fc7-e053-2995a90a429b
Set id: bdb36b09-8e1a-5f23-e053-2995a90a4a1e
Version: 1
Effective Time: 20210316
 
AJ Co., Ltd.