LUCKY ANTIBACTERIAL DEODORANT- triclocarban soap
Delta Brands Inc.

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

Triclocarban 0.30%

Purpose

Antibacterial

Uses

■for hand washing to decrease bacteria on the skin

Warnings

For external use only

When using this product

■avoid contact with eyes. In case of eye contact, flush with water

Stop use and ask a doctor if

■irritation and redness develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ wet bar with water ■ lather vigorously and wash skin ■ rinse and dry thoroughly

Inactive ingredients

sodium palm kernelate, sodium palmate, water, fragrance, glycerin, sodium chloride, tetrasodium EDTA, FD&C yellow no. 5, FD&C red no. 4

Package Label

package label

LUCKY ANTIBACTERIAL DEODORANT
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:20276-048
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)	TRICLOCARBAN	0.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM PALMITATE (UNII: JQ43KP6296)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:20276-048-30	90 g in 1 BOX; Type 0: Not a Combination Product	04/15/2016
2	NDC:20276-048-35	100 g in 1 BOX; Type 0: Not a Combination Product	04/15/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/15/2016

Labeler - Delta Brands Inc. (102672008)