MOIST WIPES- benzalkonium chloride lotion 
Shanghai Yinjing Medical Supplies Co., Ltd.

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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Active ingredient

Benzalkonium chloride 0.1%

Purpose

Antibacterial

Use   decreases bacteria on skin

Warnings

For external use only

Do not use

-over large areas of the body

-if you are allergic to any of the ingredients

When using this product avoid contact with eyes and face.

If contact occurs, flush thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and

continues for more than 72 hours

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away

Directions

-for adults and children of 2 years and over

-children under 2 years ask a doctor before using

-allow to dry without wiping

Other information  store at room temperature

Inactive ingredient

Water, Glycerin, Phenoxyethanol, Polysorbate 20, Aloe Barabdensis

Leaf Extract, Polyaminopropyl Biguianide, Disodium EDTA,

Fragrance, 2-Bromo-2 Nitroporpane 1,3 Diol, Tocopheryl Acetate

image description

MOIST WIPES 
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55310-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BRONOPOL (UNII: 6PU1E16C9W)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55310-002-0220 in 1 BAG06/15/2016
1NDC:55310-002-01.1 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/2016
Labeler - Shanghai Yinjing Medical Supplies Co., Ltd. (530501535)

Revised: 6/2016
Document Id: 68198485-2b8e-410b-8fa8-dd947697d2b4
Set id: da162393-9f82-4bc9-9fa3-75b0d257a314
Version: 1
Effective Time: 20160615
 
Shanghai Yinjing Medical Supplies Co., Ltd.