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Gentle Rain Antibacterial

Dosage form: shampoo
Ingredients: TRICLOSAN 3mL in 1000mL
Labeler: Coloplast Manufacturing US, LLC
NDC Code: 11701-018

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.

Gentle Rain® Antibacterial
New Indication:
Hand Washing
Bathing & Hand Washing
Antibacterial Moisturizing Body Wash, Shampoo & Hand Wash

For Full-Body Bathing & Antiseptic Hand Washing

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 - 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)

GENTLE RAIN ANTIBACTERIAL  
triclosan shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-018
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN3 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
IMIDUREA 
COCAMIDOPROPYL BETAINE 
AMMONIUM LAURETH-3 SULFATE 
AMMONIUM LAURYL SULFATE 
GLYCERIN 
PROPYLENE GLYCOL 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
CITRIC ACID 
SODIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:11701-018-0359 mL in 1 BOTTLE
2NDC:11701-018-04118 mL in 1 BOTTLE
3NDC:11701-018-26621 mL in 1 BOTTLE
4NDC:11701-018-461000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/15/2009
Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
NameAddressID/FEIOperations
Coloplast Manufacturing US, LLC110326675MANUFACTURE

Revised: 06/2011
 
Coloplast Manufacturing US, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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