GENTLE RAIN ANTIBACTERIAL - triclosan shampoo 
Coloplast Manufacturing US, LLC

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.

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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)

PRINCIPAL DISPLAY PANEL - 2 FL. OZ. (59 mL)
GENTLE RAIN ANTIBACTERIAL  
triclosan shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11701-018-0359 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/200909/06/2017
2NDC:11701-018-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/200909/06/2017
3NDC:11701-018-26621 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/200909/06/2017
4NDC:11701-018-461000 mL in 1 BAG; Type 0: Not a Combination Product06/15/200909/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/15/200909/06/2017
Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
NameAddressID/FEIBusiness Operations
Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-018)

Revised: 2/2018
Document Id: 9fd6d074-f223-4d33-a6df-b4d67629f9fe
Set id: ff174544-ea02-47a0-882f-da0a67b27994
Version: 4
Effective Time: 20180221
 
Coloplast Manufacturing US, LLC