Label: FAMILY DOLLAR ANTIBACTERIAL- benzethonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55319-430-40, 55319-430-75 - Packager: Family Dollar Services Inc.
- 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 October 26, 2016
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
FAMILY DOLLAR ANTIBACTERIAL
benzethonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-430 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.1 g in 100 mL Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 5 (UNII: I753WB2F1M) WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) D&C RED NO. 33 (UNII: 9DBA0SBB0L) GLYCERIN (UNII: PDC6A3C0OX) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) COCO MONOETHANOLAMIDE (UNII: C80684146D) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BENZOATE (UNII: OJ245FE5EU) EDETATE SODIUM (UNII: MP1J8420LU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-430-75 221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/19/2016 2 NDC:55319-430-40 1180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/19/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/19/2016 Labeler - Family Dollar Services Inc. (024472631)