SAN SKINLAB CLOTH WET WIPES- benzalkonium chloride 0.13% cloth

SAN Skinlab Cloth Wet Wipes by

Drug Labeling and Warnings

SAN Skinlab Cloth Wet Wipes by is a Otc medication manufactured, distributed, or labeled by BACTEC CO LTD., HANUL CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.13%. Purpose: Antiseptic

Purpose

Antiseptic,

Use

to decrease bacteria on the skin that could cause disease

Warnings

For external use only.

WHEN USING

Keep out of eyes, in case of contact with eyes, flush thoroughly with water, Avoid contact with broken skin, Do Not inhale or ingest

STOP USE

Stop use and ask a doctor if irritation or redness developes condition persist for more than 72 hours.

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

Wet hands thoroughly with product and allow to dry without wiping

Not recommended for infants

Other information

• Do not Store above 105F/40 Degree .Do not Freeze
• Dispose of used wipe in trash, do not flush into toilet

Inactive ingredients

Water ( Aqua) , Alcohol ( Ethanol). Glycerin,Butylene Glycol, Aloe Vera, Citric Acid, 1,2 hexanediol

Package Label - Principal Display Panel

120 Wet wipes NDC: 81764-120-01

INGREDIENTS AND APPEARANCE

SAN SKINLAB CLOTH WET WIPES 
benzalkonium chloride 0.13% cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81764-120
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALCOHOL (UNII: 3K9958V90M)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81764-120-01	798 mL in 1 CANISTER; Type 0: Not a Combination Product	04/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/12/2021

Labeler - BACTEC CO LTD. (695826213)

Establishment
Name	Address	ID/FEI	Business Operations
HANUL CO., LTD		557814370	manufacture(81764-120)