TOPCARE MANDARIN- triclosan liquid
TOPCO ASSOCIATES LLC

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 0.6%

PURPOSE

ANTIBACTERIAL

USES

HELPS REDUCE BACTERIA ON THE SKIN

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOP

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS

PUMP ONTO DRY HANDS, WORK INTO A LATHER AND RINSE THOROUGHLY

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), SODIUM XYLENESULFONATE, DIPROPYLENE GLYCOL, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, FRAGRANCE (PARFUM), DISODIUM PHOSPHATE, CITRIC ACID, RED 4 (CI 14700), YELLOW 5 (CI 19140)

LABEL COPY

IMAGE OF THE LABEL

TOPCARE MANDARIN
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-366
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	6 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-366-08	222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/18/2014	09/23/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/18/2014	09/23/2014

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(36800-366)

Revised: 9/2016

Document Id: 523e8d0d-17e6-4ff4-ba81-bf6a8f4b9d58

Set id: 18a8f4d0-155e-40cf-8394-c72330cf3b99

Version: 2

Effective Time: 20160914

TOPCO ASSOCIATES LLC