top care calagesic lotion

top care calagesic lotion
SPL v5
SPL
SPL Set ID 8dced3ea-147b-3d46-e053-2a95a90aa1c0
Route
topical
Published
Effective Date 2019-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (80 mg) pramoxine (10 mg)
Inactive Ingredients
glycerin camphor (natural) polysorbate 80 propylene glycol diazolidinyl urea water methylparaben propylparaben

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-07-16

Description

Calamine 8% Pramoxine Hydochloride 1%


Medication Information

Warnings and Precautions

For external use only. Use only as directed.

When using this product. Avoid contact with eyes and moucous membranes.

Active Ingredient

Calamine 8%

Pramoxine Hydochloride 1%

Indications and Usage

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.

Dosage and Administration

Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 yrs. of age. Consult a doctor before use.

Description

Calamine 8% Pramoxine Hydochloride 1%

Section 50565-1

In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately.

Section 51727-6

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.

Section 51945-4

Section 55105-1

Skin Protectant

External analgesic


Structured Label Content

Warnings and Precautions (34071-1)

For external use only. Use only as directed.

When using this product. Avoid contact with eyes and moucous membranes.

Active Ingredient (55106-9)

Calamine 8%

Pramoxine Hydochloride 1%

Indications and Usage (34067-9)

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.

Dosage and Administration (34068-7)

Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 yrs. of age. Consult a doctor before use.

Section 50565-1 (50565-1)

In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

External analgesic


Advanced Ingredient Data


Raw Label Data

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