SAFEGUARD- triclosan soap
Procter & Gamble Manufacturing Company

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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Safeguard Antibacterial Hand Soap

Drug Facts

Active ingredient

Triclosan 0.25%

Purpose

Antibacterial

Use

For handwashing to decrease bacteria on the skin.

WARNINGS

For external use only.

Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a Posion Control Center right away.

Directions

Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Rinse with water after rubbing hands for 20 seconds.

Inactive ingredients

water, sodium lauryl sulfate, sodium laureth sulfate, lauramide DEA, glycol distearate, cocamidopropyl betaine, sodium sulfate, fragrance, guar hydroxypropyltrimonium chloride, citric acid, DMDM hydantoin, tetrasodium EDTA, red 4, yellow 5

Questions?

1-800-595-1375

DIST. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202.

PRINCIPAL DISPLAY PANEL - 48 FL OZ Bottle Label

Eliminates 99% of
bacteria on Hands

Frequent hand washing
helps keep your family
healthy.

Safeguard®
Antibacterial

Triclosan
Antibacterial
Hand Soap Refill

48 FL OZ (1.42 L)

PRINCIPAL DISPLAY PANEL - 48 FL OZ Bottle Label

SAFEGUARD
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-600
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X)	Triclosan	0.25 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
sodium lauryl sulfate (UNII: 368GB5141J)
sodium laureth-3 sulfate (UNII: BPV390UAP0)
Lauric Diethanolamide (UNII: I29I2VHG38)
glycol distearate (UNII: 13W7MDN21W)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
sodium sulfate (UNII: 0YPR65R21J)
guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) (UNII: B16G315W7A)
citric acid monohydrate (UNII: 2968PHW8QP)
DMDM hydantoin (UNII: BYR0546TOW)
Edetate Sodium (UNII: MP1J8420LU)
fd&c red no. 4 (UNII: X3W0AM1JLX)
fd&c yellow no. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:37000-600-01	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:37000-600-02	800 mL in 1 BAG; Type 0: Not a Combination Product
3	NDC:37000-600-03	221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
4	NDC:37000-600-04	1420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/01/2001	12/31/2016

Labeler - Procter & Gamble Manufacturing Company (004238200)

Name	Address	ID/FEI	Business Operations
Establishment
Kleen Test Products		168165814	ANALYSIS(37000-600) , MANUFACTURE(37000-600) , RELABEL(37000-600) , REPACK(37000-600)

Revised: 5/2015

Document Id: 4769b597-c929-43e7-ab80-382e9563abed

Set id: e1074840-dbe2-404f-ac0b-a06876a70c66

Version: 2

Effective Time: 20150511

Procter & Gamble Manufacturing Company