Label: BEDSIDE-CARE- benzethonium chloride shampoo
Contains inactivated NDC Code(s)
NDC Code(s): 11701-053-04, 11701-053-05
- Packager: Coloplast Manufacturing US, LLC
- 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.
Updated February 15, 2018
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- SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
When using this product: do not use in the eyes, with deep or puncture wounds, serious burns, or animal bites.
Stop using this product if:
- if skin irritation and redness develop
- if condition persists for more than 7 days, consult a physician.
Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Inactive ingredients purified water, sodium lauroamphoacetate, cocamidopropyl betaine, glycerin, polysorbate 20, quaternium-52, citric acid, quaternium-15, tetrasodium EDTA.
Protocol: Rinsing is not required. Aids in the removal of urine, feces and other foreign material. Cleansing: apply to the affected area and remove with a moist washcloth. Bathing: dispense 3-4 pumps in a basin with warm water and cleanse the skin. Shampooing: pump foam directly on dampened hair, lather and remove with a moist washcloth.
Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp., Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.us.coloplast.com ©2007, Coloplast Corp.
Product #7146 Made in the U.S.A.
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
INGREDIENTS AND APPEARANCE
benzethonium chloride shampoo
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11701-053 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 100 mg in 100 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) QUATERNIUM-15 (UNII: E40U03LEM0) GLYCERIN (UNII: PDC6A3C0OX) QUATERNIUM-52 (UNII: 588EQF3H1P) POLYSORBATE 20 (UNII: 7T1F30V5YH) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11701-053-04 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/15/2009 2 NDC:11701-053-05 237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/15/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/15/2009 Labeler - Coloplast Manufacturing US, LLC (110326675) Registrant - Coloplast Corp (847436391) Establishment Name Address ID/FEI Business Operations Coloplast Manufacturing US, LLC 110326675 MANUFACTURE(11701-053)