Label: SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS WHITE TEA AND BERRY FUSION- benzalkonium chloride liquid
- NDC Code(s): 35000-081-11, 35000-081-55, 35000-081-75, 35000-081-91
- Packager: Colgate-Palmolive 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 December 10, 2019
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Inactive ingredients
water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, sodium chloride, fragrance, PEG-120 methyl glucose dioleate, citric acid, tetrasodium EDTA, prunus persica (peach) juice, fragaria ananassa (strawberry) fruit juice, rubus idaeus (raspberry) juice, fructose, methylchloroisothiazolinone, methylisothiazolinone, prunus amygdalus dulcis (sweet almond) seed extract, red 33, blue 1
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- PRINCIPAL DISPLAY PANEL - 1478 mL Bottle Label
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INGREDIENTS AND APPEARANCE
SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS WHITE TEA AND BERRY FUSION
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.33 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) GLYCERIN (UNII: PDC6A3C0OX) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) COCO MONOETHANOLAMIDE (UNII: C80684146D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) PEACH JUICE (UNII: K37IH01KN1) STRAWBERRY JUICE (UNII: U8NS58UGW0) RASPBERRY JUICE (UNII: 427AYI9PDE) FRUCTOSE (UNII: 6YSS42VSEV) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) ALMOND (UNII: 3Z252A2K9G) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE (Light blue) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-081-91 1478 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/04/2019 2 NDC:35000-081-75 221 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/20/2015 3 NDC:35000-081-55 1650 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/20/2015 4 NDC:35000-081-11 332 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/20/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 05/20/2015 Labeler - Colgate-Palmolive Company (001344381) Establishment Name Address ID/FEI Business Operations Colgate-Palmolive Company 079342773 ANALYSIS(35000-081) , MANUFACTURE(35000-081) , PACK(35000-081) , LABEL(35000-081)