ANTIBACTERIAL HAND WIPES- wipes cloth

Antibacterial Hand Wipes by

Drug Labeling and Warnings

Antibacterial Hand Wipes by is a Otc medication manufactured, distributed, or labeled by Osike Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Use

●Hand sanitizer to help reduce bacteria
●For use when soap and water are not available.

Warnings

For external use only.

Do not use
●in children less than 2 months old.
●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.

Do not use

●in children less than 2 months old.
●on open skin wounds

WHEN USING

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

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

Keep out of reach of children. If swallowed. get medical help or contact a Poison Control Center right away.

Directions

●Apply to hands, allow to air dry without wiping.
●Children under 6 years of age should be supervised when using this product

Other information

●Store in a cool, dry place.
●Avoid freezing and excessive heat.

Inactive ingredients

Aloe Barbadensis Extract, Alpha-Tocopherol, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND WIPES 
wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79866-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79866-008-01	75 in 1 DRUM; Type 0: Not a Combination Product	09/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/16/2020

Labeler - Osike Cosmetics Co., Ltd. (415803943)

Establishment
Name	Address	ID/FEI	Business Operations
Osike Cosmetics Co., Ltd.		415803943	manufacture(79866-008)