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Gentle Rain Antibacterial (Coloplast Manufacturing US, LLC)

Available Formats

Dosage Form Package Information Links
SHAMPOO 1000 mL in 1 BAG (11701-018-46) Label Information
SHAMPOO 59 mL in 1 BOTTLE (11701-018-03) Label Information
SHAMPOO 118 mL in 1 BOTTLE (11701-018-04) Label Information
SHAMPOO 621 mL in 1 BOTTLE (11701-018-26) Label Information

Complete Gentle Rain Antibacterial Information

  • SPL UNCLASSIFIED SECTION

    For Full-Body Bathing & Antiseptic Hand Washing


  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active ingredients

    Triclosan, 0.3%

    Purpose

    Antimicrobial and antiseptic hand wash

    Uses Reduces bacteria on the hands and body to protect against skin infection.

    Warnings

    When using this product

    • avoid contact with eyes.
    • In case of deep or puncture wounds, animal bites or serious burns, consult a physician

    Stop using this product:

    • if skin irritation and redness develop
    • if condition persists for more than 7 days, consult a physician.

    For external use only.

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    • Bathing: Apply to a warm, moist washcloth and gently wash skin. Rinse thoroughly and pat dry.
    • Hand washing: Wet hands and forearms. Apply a palmful. Scrub and rinse thoroughly.

    Inactive ingredients water, ammonium lauryl sulfate ammonium laureth sulfate, cocoamidopropyl betaine, propylene glycol, glycerin, citric acid, sodium chloride, imidazolidinyl urea fragrance, methylparaben, propylparaben

    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
    Product #7201 ©2007, Coloplast Corp. Made in the U.S.A.
    H7-996


  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 2 FL. OZ. (59 mL)

    NDC 11701-018-03

    New Indication: Hand Washing

    Gentle Rain® Antibacterial

    Antibacterial Moisturizing Body Wash, Shampoo & Hand Wash

    For Full-Body Bathing & Antiseptic Hand Washing

    Coloplast

    2 FL. OZ. (59 mL)

    PRINCIPAL DISPLAY PANEL - 2 FL. OZ. (59 mL)

  • INGREDIENTS AND APPEARANCE
    GENTLE RAIN ANTIBACTERIAL  
    triclosan shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11701-018
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3 mL  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    IMIDUREA (UNII: M629807ATL)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11701-018-03 59 mL in 1 BOTTLE
    2 NDC:11701-018-04 118 mL in 1 BOTTLE
    3 NDC:11701-018-26 621 mL in 1 BOTTLE
    4 NDC:11701-018-46 1000 mL in 1 BAG
    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