Label: XTRACARE WET WIPES- benzethonium chloride swab
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Contains inactivated NDC Code(s)
NDC Code(s): 58503-062-01 - Packager: China Ningbo Shangge Cosmetic Technology Corp
- 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 September 13, 2019
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
XTRACARE WET WIPES
benzethonium chloride swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-062 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 3 mg in 100 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) EDETATE DISODIUM (UNII: 7FLD91C86K) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58503-062-01 18 in 1 PACKAGE 03/13/2014 1 100 mg in 1 APPLICATOR; 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 part333E 03/13/2014 Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp 529287434 manufacture(58503-062)