CVS HEALTH MAXIMUM STRENGTH DANDRUFF ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF- selenium sulfide shampoo

CVS Health MAXIMUM STRENGTH Dandruff by

Drug Labeling and Warnings

CVS Health MAXIMUM STRENGTH Dandruff by is a Otc medication manufactured, distributed, or labeled by CVS Health, Garcoa, Inc., Sigan Industries INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Selenium sulfide 1%

Purpose

Anti-Seborrheic Dermatitis, anti-dandruff

Use

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

Warnings

For external use only.

Ask a doctor before using this product if

• condition covers a large area of the body.

When using this product

• avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
• for 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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• shake well
• shampoo, then rinse thoroughly for best results, use at least twice a week or as directed by a doctor.

Other information

• store at room temperature

Inactive ingredients

water, ammonium lauryl sulfate, ammonium laureth sulfate, distearyl phthalic acid amide, cocamide MEA, fragrance, titanium dioxide, dimethicone, hydroxypropyl methylcellulose, citric acid, sodium lauroyl lactylate, aloe barbadensis leaf juice, sodium citrate, sodium chloride, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 10, ext. violet 2.

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

CVS
Health®

Compare to the active
ingredient in Selsun
Blue® Moisturizing
Dandruff Shampoo*

MAXIMUM STRENGTH

Dandruff
Shampoo

SELENIUM SULFIDE 1%

• For the relief of seborrheic
  dermatitis & dandruff symptoms
• Helps control flakes & itching
• For healthier-looking hair & scalp

MOISTURIZING
+ ALOE

PARABEN
PHTHALATE
FREE

11 FL OZ (325 mL)

05-4270

INGREDIENTS AND APPEARANCE

CVS HEALTH MAXIMUM STRENGTH DANDRUFF   ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-387
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
Water (UNII: 059QF0KO0R)
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)
AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)
DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Titanium Dioxide (UNII: 15FIX9V2JP)
Dimethicone (UNII: 92RU3N3Y1O)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Sodium Lauroyl Lactylate (UNII: 7243K85WFO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Sodium Chloride (UNII: 451W47IQ8X)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-387-01	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M032	08/28/2024

Labeler - CVS Health (062312574)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC		255106239	MANUFACTURE(51316-387) , LABEL(51316-387) , PACK(51316-387)