ANTIBACTERIAL WIPES- benzethonium chloride swab
TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY

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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antibacterial wipes 70031 001

Active ingredient

Benzalkonium chloride 0.3%

Purpose

Antiseptic

Use

hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only.
Flammabel.keep away from heat and flame.

do not use in the eyes,in case of caotact,rinse eyes thoroughly with water.

stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours.

Keep out of reach of children

if swallowed

get medical help or contact a Poison Control Center

Directions

tear open packet,remove and unfold wipe.

thoroughly wipe hands (palms ,backs and between fingers)

supervise children in use of this product

aloe barbadensis leaf juice,citric acid,disodium EDTA,ethyl alcohol ,fragrance,methylparaben,PEG-60 lanolin,PEG-dimethicone,potassium sorbate,propylparaben,quaternium-52,water(aqua)

label

ANTIBACTERIAL WIPES
benzethonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70031-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETIC ACID (UNII: 9G34HU7RV0)
ALCOHOL (UNII: 3K9958V90M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POTASSIUM BENZOATE (UNII: 763YQN2K7K)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70031-001-01	12 in 1 BAG	01/08/2018
1		0.0108 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:70031-001-02	1 in 1 BAG	01/08/2018
2		0.0108 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:70031-001-03	1 in 1 BOTTLE, PLASTIC	01/08/2018
3		0.0108 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC:70031-001-04	5 in 1 BAG	01/08/2018
4		0.0108 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC:70031-001-06	6 in 1 BAG	01/08/2018
5		0.0108 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/05/2015

Labeler - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791)

Registrant - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791)

Name	Address	ID/FEI	Business Operations
Establishment
TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY		679914791	manufacture(70031-001)