DIGNITY HEALTH MEDSPA ANTIBACTERIAL- triclosan soap
Jiangsu Xinheyuan Plastic Daily Chemical Co., Ltd.

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 0.3%

Purpose

Antibacterial

Uses

for 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.

Don't use this product on infants under 6 months of age.

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

Water, calcium carbonate, fragrance, glycerine, sodium chloride, sodium palmate

label image

DIGNITY HEALTH MEDSPA ANTIBACTERIAL
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69688-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM PALMATE (UNII: S0A6004K3Z)
CALCIUM CARBONATE (UNII: H0G9379FGK)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description
Packaging
1	NDC:69688-001-01	200 in 1 BOX
1		21 g in 1 PACKAGE; 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	06/09/2015

Labeler - Jiangsu Xinheyuan Plastic Daily Chemical Co., Ltd. (527743312)

Name	Address	ID/FEI	Business Operations
Establishment
Jiangsu Xinheyuan Plastic Daily Chemical Co., Ltd.		527743312	manufacture(69688-001)