CARE ONE VANILLA APPLE BLOSSOM- triclosan liquid

CARE ONE by

Drug Labeling and Warnings

CARE ONE by is a Otc medication manufactured, distributed, or labeled by AMERICAN SALES COMPANY, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

TRICLOSAN 0.46%

PURPOSE

ANTIBACTERIAL

USES

FOR WASHING TO DECREASE 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 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 DRY HANDS, WORK INTO A RICH FOAMY LATHER, RINSE AND DRY THOROUGHLY.

INACTIVE INGREDIENTS:

WATER (AQUA), SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, SODIUM XYLENESULFONATE, PEG-8, FRAGRANCE (PARFUM), SODIUM PCA, DISODIUM PHOSPHATE, ALOE BARBADENSIS LEAF JUICE, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 33 (CI 17200), BLUE 1 (CI 42090), YELLOW 5 (ci 19140).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CARE ONE  VANILLA APPLE BLOSSOM
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-198
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	4.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-198-08	237 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/20/2013

Labeler - AMERICAN SALES COMPANY (809183973)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(41520-198)