CVS HEALTH MAXIMUM STRENGTH THERAPEUTIC DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS- salicylic acid shampoo

CVS Health MAXIMUM STRENGTH Therapeutic Dandruff by

Drug Labeling and Warnings

CVS Health MAXIMUM STRENGTH Therapeutic 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

Salicylic acid 3.0%

Purpose

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Uses

controls the symptom of:

• dandruff
• seborrheic dermatitis
• psoriasis

Warnings

For external use only.

Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product

• ⬥ avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

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

• ⬥ for best results use at least twice a week or as directed by a doctor.
• ⬥ wet hair thoroughly.
• ⬥ massage shampoo into the scalp.
• ⬥ lather, leave on hair and scalp for several minutes.
• ⬥ rinse and repeat.

Other information

• store at room temperature
• store away from direct sunlight

Inactive ingredients

water, sodium C14-16 olefin sulfonate, sodium laureth sulfate, cocamidopropyl betaine, cocamide MEA, PEG-150 distearate, polyquaternium-10, propylene glycol, sodium citrate, sodium hydroxide

Questions or comments?

1-866-567-8600

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

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

CVS
Health®

Compare to the
active ingredient in
Neutrogena® T/Sal®
Therapeutic Shampoo
Scalp Build-Up Control**

MAXIMUM STRENGTH

Therapeutic
Dandruff
Shampoo
3% SALICYLIC ACID

Helps stop & prevent
flakes & scalp buildup

Controls the symptoms
of psoriasis, seborrheic
dermatitis & dandruff

PARABEN
PHTHALATE
FREE

4.5 FL OZ (133 mL)

INGREDIENTS AND APPEARANCE

CVS HEALTH MAXIMUM STRENGTH THERAPEUTIC DANDRUFF   ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-443
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-150 Distearate (UNII: 6F36Q0I0AC)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
Propylene Glycol (UNII: 6DC9Q167V3)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Sodium Hydroxide (UNII: 55X04QC32I)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-443-01	1 in 1 CARTON	08/28/2024
1		133 mL in 1 BOTTLE; Type 0: Not a Combination Product

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(51316-443) , LABEL(51316-443) , PACK(51316-443)