Label: ANTIMICROBIAL FOAMING- benzethonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63148-241-12 - Packager: APOLLO HEALTH AND BEAUTY CARE
- 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 July 22, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DIRECTIONS
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INACTIVE INGREDIENTS
WATER, COCAMIDOPROPYL BETAINE, GLYCERIN, DECYL GLUCOSIDE, POLYQUATERNIUM-7, FRAGRANCE, CAMELLIA SINENSIS, ZINGIBER OFFICINALE, HIBISCUS SABDARIFFA, CHAMOMILA RECUTITA, CITRIC ACID, ORIGANUM VULGARE LEAF EXTRACT, THYMUS VULGARE (THYME) EXTRACT, CINNAMOMUM ZEYLANICUM BARK EXTRACT, ROSEMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) ROOT EXTRACT, TETRASODIUM EDTA, GREEN 5, RED 33, YELLOW 5.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIMICROBIAL FOAMING FALLING RAIN
benzethonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-241 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 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GINGER (UNII: C5529G5JPQ) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) CHAMOMILE (UNII: FGL3685T2X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) OREGANO (UNII: 0E5AT8T16U) THYME (UNII: CW657OBU4N) CINNAMON BARK OIL (UNII: XE54U569EC) ROSEMARY (UNII: IJ67X351P9) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) GOLDENSEAL (UNII: ZW3Z11D0JV) EDETATE SODIUM (UNII: MP1J8420LU) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63148-241-12 354 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/22/2011 Labeler - APOLLO HEALTH AND BEAUTY CARE (201901209) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture