Label: MOIST WIPES- benzalkonium chloride lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 55310-002-01, 55310-002-02 - Packager: Shanghai Yinjing Medical Supplies Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 15, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOIST WIPES
benzalkonium chloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55310-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE .1 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:55310-002-02 20 in 1 BAG 06/15/2016 1 NDC:55310-002-01 .1 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/15/2016 Labeler - Shanghai Yinjing Medical Supplies Co., Ltd. (530501535)
