Tera-gel Shampoo

Tera-gel Shampoo
SPL v1
SPL
SPL Set ID 6f079fa9-2fa2-4988-ae1b-46b8fd670fac
Route
TOPICAL
Published
Effective Date 2016-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Coal Tar (0.57 g)
Inactive Ingredients
Water Coco Diethanolamide Polysorbate 20 Polysorbate 80 Citric Acid Monohydrate Cocamidopropyl Betaine Dmdm Hydantoin Methylparaben Propylparaben Sodium Chloride Sodium Laureth Sulfate Edetate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-07-31

Description

Active Ingredient Purpose 0.5% Coal Tar . . . . . . . . . . . . . . . Anti-Dandruff, Anti-Seborrheic Dermatitis, Anti-Psoriasis


Medication Information

Dosage and Administration

For best results, use at least twice a week or as directed by a physician.

Description

Active Ingredient Purpose 0.5% Coal Tar . . . . . . . . . . . . . . . Anti-Dandruff, Anti-Seborrheic Dermatitis, Anti-Psoriasis

Uses

To control the symptoms of dandruff,

seborrheic dermatitis, and psoriasis

Section 44425-7

15°-30°C (59°-86°F).

Section 50565-1

Keep out of reach of children. If swallowed get prompt medical

attention or contact a poison control center immediately.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY

Consult a physician before use if you have a condition that

covers a large area of the body. Consult a physician or pharmacist

before using if you intend to use this product with other forms of

psoriasis therapy such as ultraviolet radiation or prescription drugs.

When using this product:

• Avoid contact with eyes. If contact occurs, rinse eyes

thoroughly with water.

• If improvement does not occur, or condition worsens after

regular use, as directed, consult a physician.

• Use caution when exposing skin to sunlight after using this

product. It may increase the tendency to sunburn for up

to 24 hours after using this product.

• Do not use for prolonged periods without consulting a doctor.

If condition worsens or does not improve after regular use of

this product as directed, stop use and consult a physician.

Directions

For best results, use at least twice a week or as directed by a physician.

• Wet hair and scalp thoroughly.

• Massage shampoo into scalp.

• Leave lather on hair and scalp for several minutes.

• Rinse and repeat

Active Ingredient

Active Ingredient Purpose

0.5% Coal Tar . . . . . . . . . . . . . . . Anti-Dandruff, Anti-Seborrheic

Dermatitis, Anti-Psoriasis

​inactive Ingredients:

Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Deionized Water, DMDM Hydantoin, Fragrance, Methylparaben, Polysorbates 20 & 80, Propylparaben, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA


Structured Label Content

Uses

To control the symptoms of dandruff,

seborrheic dermatitis, and psoriasis

Dosage and Administration (34068-7)

For best results, use at least twice a week or as directed by a physician.

Section 44425-7 (44425-7)

15°-30°C (59°-86°F).

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get prompt medical

attention or contact a poison control center immediately.

Section 51945-4 (51945-4)

Warnings

FOR EXTERNAL USE ONLY

Consult a physician before use if you have a condition that

covers a large area of the body. Consult a physician or pharmacist

before using if you intend to use this product with other forms of

psoriasis therapy such as ultraviolet radiation or prescription drugs.

When using this product:

• Avoid contact with eyes. If contact occurs, rinse eyes

thoroughly with water.

• If improvement does not occur, or condition worsens after

regular use, as directed, consult a physician.

• Use caution when exposing skin to sunlight after using this

product. It may increase the tendency to sunburn for up

to 24 hours after using this product.

• Do not use for prolonged periods without consulting a doctor.

If condition worsens or does not improve after regular use of

this product as directed, stop use and consult a physician.

Directions

For best results, use at least twice a week or as directed by a physician.

• Wet hair and scalp thoroughly.

• Massage shampoo into scalp.

• Leave lather on hair and scalp for several minutes.

• Rinse and repeat

Active Ingredient

Active Ingredient Purpose

0.5% Coal Tar . . . . . . . . . . . . . . . Anti-Dandruff, Anti-Seborrheic

Dermatitis, Anti-Psoriasis

​inactive Ingredients: (​Inactive Ingredients:)

Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Deionized Water, DMDM Hydantoin, Fragrance, Methylparaben, Polysorbates 20 & 80, Propylparaben, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA


Advanced Ingredient Data


Raw Label Data

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