BCP- benzalkonium chloride cloth
BELSKIN S. DE, R.L. DE C.V

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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ANTISEPTIC WET WIPES

ACTIVE INGREDIENTS

Benzalkonium chloride

Ethyl Alcohol

INACTIVE INGREDIENTS

WATER, ALOE VERA LEAF, ANHYDROUS CITRIC ACID, DIMETHICONE, GLYCERIN, EDETATE SODIUM TETRAHYDRATE, ALPHA TOCOPHEROL ACETATE, HYDANTOIN, POLYSORBATE 20, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE

WARNINGS AND PRECAUTIONS

Children under 6 years of age should be supervised when using.

If swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS

For external use only. Flammable. Keep away from heat or flame

DOSAGE AND ADMINISTRATION

APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING.

PURPOSE

ANTIBACTERIAL

STOP USE

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH DEVELOPS AND CONTINUES FOR MORE THAN 72 HOURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

INDICATIONS AND USAGE

APPLY TO HANDS AND ALLOW TO DRY WITHOUT WIPING.

PACKAGE LABEL

LABEL ANTISEPTIC WIPES

BCP
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78502-7000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	5 g in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.25 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.05 g in 100 g
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	0.08 g in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.005 g in 100 g
WATER (UNII: 059QF0KO0R)	93.885 g in 100 g
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)	0.1 g in 100 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	0.1 g in 100 g
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)	0.008 g in 100 g
HYDANTOIN (UNII: I6208298TA)	0.002 g in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.015 g in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	0.5 g in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O)	0.005 g in 100 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78502-7000-1	30 g in 1 BAG; Type 0: Not a Combination Product	07/04/2020
2	NDC:78502-7000-2	40 g in 1 BAG; Type 0: Not a Combination Product	07/04/2020
3	NDC:78502-7000-3	5 g in 1 BAG; Type 0: Not a Combination Product	07/04/2020
4	NDC:78502-7000-4	12 g in 1 BAG; Type 0: Not a Combination Product	07/04/2020
5	NDC:78502-7000-5	20 g in 1 BAG; Type 0: Not a Combination Product	07/04/2020
6	NDC:78502-7000-6	100 g in 1 BAG; Type 0: Not a Combination Product	07/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/04/2020

Labeler - BELSKIN S. DE, R.L. DE C.V (816649743)

Registrant - BELSKIN S. DE, R.L. DE C.V (816649743)

Name	Address	ID/FEI	Business Operations
Establishment
BELSKIN S. DE, R.L. DE C.V		816649743	manufacture(78502-7000)