Label: ASSURED- benzalkonium chloride lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70031-002-01, 70031-002-02 - Packager: TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY
- 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 August 31, 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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASSURED
benzalkonium chloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70031-002 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) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG-54 HYDROGENATED CASTOR OIL (UNII: 0WZF1506N9) EDETATE DISODIUM (UNII: 7FLD91C86K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYL SOYATE (UNII: 808DL597QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70031-002-02 20 in 1 BAG 08/31/2016 1 NDC:70031-002-01 .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 08/31/2016 Labeler - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791)
