CVS HEALTH VITAMIN A AND D SKIN PROTECTANT- lanolin and petrolatum ointment

CVS Health Vitamin A and D by

Drug Labeling and Warnings

CVS Health Vitamin A and D by is a Otc medication manufactured, distributed, or labeled by CVS Health, Garcoa, Inc., Sigan America, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Solubilized Coal Tar Extract 2.50% (Coal Tar, 0.50%)

Purpose

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

Use

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
• use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
• do not use for prolonged periods without consulting a doctor.
• do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.

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 away from direct sunlight

• in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur

Inactive ingredients

water, sodium laureth sulfate, cocamide MEA, cocamidopropyl betaine, laureth-4, fragrance, polysorbate 20, citric acid, sodium chloride, disodium EDTA, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6.

Questions or comments?

1-866-567-8600

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Distributed By: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152, USA

PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

NDC: 0904-5259-44

MAJOR®

Thera-Gel™
THERAPEUTIC
SHAMPOO

ORIGINAL FORMULA

Coal Tar 0.5%

Long Lasting Relief of
Itching and Flaking

Controls the Symptoms of:

• Seborrheic Dermatitis
• Psoriasis
• Dandruff

05-1439A

*Compare to the active ingredient of
Neutrogena® T/Gel® Therapeutic Shampoo

8.5 FL OZ (251 mL)

INGREDIENTS AND APPEARANCE

CVS HEALTH VITAMIN A AND D  SKIN PROTECTANT
lanolin and petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-399
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lanolin (UNII: 7EV65EAW6H) (Lanolin - UNII:7EV65EAW6H)	Lanolin	155 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	534 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Cod Liver Oil (UNII: BBL281NWFG)
Soybean Lecithin (UNII: 1DI56QDM62)
Microcrystalline Wax (UNII: XOF597Q3KY)
Mineral Oil (UNII: T5L8T28FGP)
Paraffin (UNII: I9O0E3H2ZE)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-399-01	454 g in 1 JAR; Type 0: Not a Combination Product	04/29/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/29/2010

Labeler - CVS Health (062312574)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan America, LLC		964976968	manufacture(51316-399)