CARE ONE PEPPERMINT SWIRL- 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 MORE THAN 7 DAYS

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

APPLY TO DRY HANDS, WORK INTO A RICH FOAMY LATHER AND RINSE THOROUGHLY

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), SODIUM LAURETH SULFATE, DISODIUM LAURETH SULFOSUCCINATE, COCAMIDOPROPYLAMINE OXIDE, POLYSORBATE 20, GLYCERIN, PEG-7 GLYCERYL COCOATE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, TETRASODIUM EDTA, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, CITRIC ACID, ALOE BARBADENSIS LEAF JUICE, BENZOPHENONE-4, HYDROXYPROPYL METHYLCELLULOSE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 33 (CI 17200), RED 4 (CI 14700), BLUE 1 (CI 42090)

LABEL COPY

INGREDIENTS AND APPEARANCE

CARE ONE  PEPPERMINT SWIRL
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-119
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)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SULISOBENZONE (UNII: 1W6L629B4K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-119-08	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	10/27/2013

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(41520-119)