Drug Facts

GERMICIDA ANTIMICROBIAL- triclosan soap
Laboratorios Roldan, S.A.

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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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66449-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	2.0 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PHENOL (UNII: 339NCG44TV)
BEEF TALLOW (UNII: 98HPY76U4W)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66449-004-01	75 g in 1 BOX

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/30/2012

Labeler - Laboratorios Roldan, S.A. (871410015)

Name	Address	ID/FEI	Business Operations
Establishment
Laboratorios Roldan, S.A.		871410015	manufacture