Top Care Calamine Lotion

Top Care Calamine Lotion
SPL v5
SPL
SPL Set ID 8dcf134e-0427-0c43-e053-2995a90a7c26
Route
TOPICAL
Published
Effective Date 2019-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (160 mg)
Inactive Ingredients
Bentonite Carrageenan Xanthan Gum Water Calcium Hydroxide Microcrystalline Cellulose Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-16

Description

Calamine 8% and Zinc Oxide 8%


Medication Information

Warnings and Precautions

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren 2 years of age.

Indications and Usage

dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Dosage and Administration

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.

Children under 2 years of age: Consult a doctor before use.

Description

Calamine 8% and Zinc Oxide 8%

Section 50565-1

In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

Section 51727-6

Bentonite magma, calcium hydroxide, glycerin, purified water.

Section 51945-4

Section 55105-1

Skin protectant

Section 55106-9

Calamine 8% and Zinc Oxide 8%

Directions

Children under 2 years of age: Consult a doctor before use (8/2021)


Structured Label Content

Indications and Usage (34067-9)

dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Dosage and Administration (34068-7)

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.

Children under 2 years of age: Consult a doctor before use.

Warnings and Precautions (34071-1)

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren 2 years of age.

Section 50565-1 (50565-1)

In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

Section 51727-6 (51727-6)

Bentonite magma, calcium hydroxide, glycerin, purified water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin protectant

Section 55106-9 (55106-9)

Calamine 8% and Zinc Oxide 8%

Directions

Children under 2 years of age: Consult a doctor before use (8/2021)


Advanced Ingredient Data


Raw Label Data

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