Label: SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS CRISP CLEAN- benzalkonium chloride liquid
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NDC Code(s):
35000-086-11,
35000-086-20,
35000-086-26,
35000-086-31, view more35000-086-34, 35000-086-55, 35000-086-73, 35000-086-75, 35000-086-80, 35000-086-91
- 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 September 1, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
- Directions
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1.47 L Bottle Label
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PRINCIPAL DISPLAY PANEL - 3.78 liter Bottle Label
PROFESSIONAL PRODUCTS
COLGATE-PALMOLIVE COMPANY
UNIQUE
FORMULAUse only with
Softsoap® ANTIBACTERIALSoftsoap®
brandANTIBACTERIAL
HAND SOAP
with light moisturizers
eliminates 99.9% of bacteriaMEETS HEALTHCARE HANDWASH STANDARDS,
GENTLE ON HANDS*Crisp
CleanIdeal for commercial use
in foodservice, office
supply, health care,
education and lodgingREFILL
1 Gallon (3.78 liters)9887070
- PRINCIPAL DISPLAY PANEL - 591 ml Bottle Label
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INGREDIENTS AND APPEARANCE
SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS CRISP CLEAN
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-086 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) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Product Characteristics Color ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-086-91 1478 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/04/2019 2 NDC:35000-086-75 221 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2013 3 NDC:35000-086-26 162 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2013 4 NDC:35000-086-11 332 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2013 5 NDC:35000-086-31 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2013 6 NDC:35000-086-55 1650 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2013 7 NDC:35000-086-34 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2013 8 NDC:35000-086-80 1 in 1 CARTON 01/19/2013 12/31/2018 8 800 mL in 1 BAG; Type 0: Not a Combination Product 9 NDC:35000-086-73 1890 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2013 10 NDC:35000-086-20 591 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 01/19/2013 Labeler - Colgate-Palmolive Company (001344381) Establishment Name Address ID/FEI Business Operations Colgate-Palmolive Company 079342773 ANALYSIS(35000-086) , MANUFACTURE(35000-086) , PACK(35000-086) , LABEL(35000-086) Establishment Name Address ID/FEI Business Operations Veepak, Inc. 874763303 MANUFACTURE(35000-086) Establishment Name Address ID/FEI Business Operations Apex 015226132 ANALYSIS(35000-086) , MANUFACTURE(35000-086) , PACK(35000-086) , LABEL(35000-086)