Label: FRESH WATER ANTIBACTERIAL FOAMING HAND- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 63148-110-07 - Packager: Apollo Health and Beauty Care 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 March 30, 2017
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- Active ingredients
- Uses
- Warnings
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- Other information
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Inactive ingredients
Water (Aqua), Cocamdiopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquaternium-7, Xanthan Gum, Propylene Glycol, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).
- Label Copy
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INGREDIENTS AND APPEARANCE
FRESH WATER ANTIBACTERIAL FOAMING HAND
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYSORBATE 20 (UNII: 7T1F30V5YH) GLYCERIN (UNII: PDC6A3C0OX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) ALOE VERA LEAF (UNII: ZY81Z83H0X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM CITRATE (UNII: 1Q73Q2JULR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63148-110-07 222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/29/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/29/2017 Labeler - Apollo Health and Beauty Care Inc. (201901209) Registrant - Apollo Health and Beauty Care Inc. (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care Inc. 201901209 manufacture(63148-110)