IMAGE ESSENTIALS ANTIBACTERIAL - triclosan soap
KMART CORPORATION

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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Active Ingredient

Triclosan 0.115%

Purpose

Antibacterial

Warnings

For external use only.

When using this product

- Avoid contact with eyes. If contact occurs, rinse with water.

Stop using this product and ask doctor if

- irritation or redness develops and lasts.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

Apply onto wet hands, work into a lather, rinse thoroughly.

Uses

Helps reduce bacteria on the skin

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Decyl Polyglucose, Sodium Chloride, Fragrance (Parfum), DMDM Hydantoin, PEG-120 Methyl Glucose Dioleate, Citric Acid, Tetrasodium EDTA, Polyquaternium-7, PEG- 7 Glyceryl Cocoate, Red 33 (CI 17200), Blue 1 (CI 42090).

Package Front and Back Labels

IE.jpg F-B LABELS

IMAGE ESSENTIALS ANTIBACTERIAL
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49738-720
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.115 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49738-720-40	1180 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/09/2010

Labeler - KMART CORPORATION (008965873)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture