GENTLE BEAST ANTIBACTERIAL WIPES- benzalkonium chloride swab

Gentle Beast Antibacterial Wipes by

Drug Labeling and Warnings

Gentle Beast Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by AJ Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride

INACTIVE INGREDIENT

water, propylene glycol, phenoxyethanol, glycerin, sodium benzoate, sodium citrate, disodium edta, polysorbate 20, citric acid, melaleuca alternifolia (tea tree) leaf oil, tocopheryl acetate

PURPOSE

Antibacterial Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Thoroughly wipe hands with wipe.

Discard properly. Not flushable.

Be sure to close lid to keep wipes moist.

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

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENTLE BEAST ANTIBACTERIAL WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75356-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.3 g  in 337 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TEA TREE OIL (UNII: VIF565UC2G)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75356-0007-1	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(75356-0007) , label(75356-0007) , pack(75356-0007)