Careone Medicated Dandruff by Spa Dent Inc / Apollo Health and Beauty Care Drug Facts

Drug Details [pdf]

CAREONE MEDICATED DANDRUFF- selenium sulfide shampoo
Spa Dent Inc

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.

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 if

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

CAREONE MEDICATED DANDRUFF
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79147-025
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 79147-025-03	325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	07/20/2021

Labeler - Spa Dent Inc (203478896)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Spa Dent Inc		203478896	manufacture(79147-025)

Revised: 7/2021

Document Id: 92cf85a7-4fbd-471d-b268-0e23ac4517af

Set id: a39f93b4-2263-472a-a547-7a8deb81dd3a

Version: 1

Effective Time: 20210726