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Germicida Antimicrobial by Laboratorios Roldan, S.A.

Dosage form: soap
Ingredients: TRICLOSAN 2.0g in 100g
Labeler: Laboratorios Roldan, S.A.
NDC Code: 66449-004

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 Facts

Active Ingredient
Triclosan 2%

Purpose
Antiseptic

Use To decrease bacteria on the skin. Recommended for repeated use.

Warnings For external use only. Do not use • on broken skin • otherwise than as directed.

When using this product • avoid with eyes or on mucous membranes

Stop use and ask a doctor if  • condition worsens • irritation or redness develops • if condition persists for more than 3 days

Keep out of the reach of children. If swallowed contact a doctor or Poison Control Center immediately.

Directions Wet skin. Rub bar vigorously over the skin for approximately 2 minutes. Rinse and repeat.

Inactive ingredients Coconut Oil, FDC Blue 1, Phenol, Tallow and titanium dioxide

Package Label


GERMICIDA  ANTIMICROBIAL
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66449-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL 
FD&C BLUE NO. 1 
PHENOL 
BEEF TALLOW 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:66449-004-0175 g in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/30/2012
Labeler - Laboratorios Roldan, S.A. (871410015)
Establishment
NameAddressID/FEIOperations
Laboratorios Roldan, S.A.871410015manufacture

 
Laboratorios Roldan, S.A.

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Medically reviewed on Jun 12, 2018

Further information

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

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