CAREONE MEDICATED DANDRUFF- selenium sulfide shampoo

Careone Medicated Dandruff by

Drug Labeling and Warnings

Careone Medicated Dandruff by is a Otc medication manufactured, distributed, or labeled by Retail Business Services, LLC, Apollo Health and Beauty Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Selenium Sulfide 1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Uses

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of recurrence.

Warnings

For external use only.

Ask a doctor before use

you have seborrheic dermatitis in areas other than the scalp.

When using this Product

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• For use on color treated or permed hair, rinse thoroughly.

Stop use and ask a doctor if

Condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• Shake well, wet hair, massage onto scalp and rinse.
• For best results, use at least twice a week or as directed by a doctor.

Other Information

Store at Room Temperature

Inactive Ingredients

Water (Aqua), Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Citric Acid, Fragrance (Parfum), Ammonium Chloride, Menthol, Sodium Hydroxide, Magnesium Aluminium Silicate, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Red 33 (Cl 17200).

Questions or comments ?

1-877-846-9949

PDP03

INGREDIENTS AND APPEARANCE

CAREONE MEDICATED DANDRUFF 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MENTHOL (UNII: L7T10EIP3A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-025-03	325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	08/26/2021

Labeler - Retail Business Services, LLC (967989935)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care		201901209	manufacture(72476-025)