Leader Calamine Clear

Drug Facts

Composition & Product

Active Ingredients

Pramoxine (10 mg) Zinc Cation (1 mg)

Inactive Ingredients

Diazolidinyl Urea Polysorbate 80 Camphor (natural) Alcohol Glycerin Hypromellose, Unspecified Methylparaben Propylene Glycol Water Propylparaben

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-01-15

Medication Information

Warnings and Precautions

For external use only. Use only as directed.

Acoid contact with eyes and mucous membranes

Ask a doctor before using on children under 2 years of age.

Indications and Usage

Temporarily Relieves Pain and Itching Associated with:

rashes due to poison ivy, poison oak, or poison sumac

insect bites

minor skin irritation

minor cuts

dries the oozing and weeping of poison ivy, poison oak and poison sumac

Dosage and Administration

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

Description

Pramoxine HCl 1% Zinc Acetate 0.1%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

Section 51727-6

SD Alcohol 38B 2.5%

Camphor

Diazolidinyl Usea

Fragrances

Glycerin

Hydroxypropyl Methylcellulose

Methylparaben

Polysorbate 80

Propylene Glycol

Propylparaben

Purified Water

Section 51945-4

Section 55105-1

External Analgesic & Skin Protectant

Section 55106-9

Pramoxine HCl 1%

Zinc Acetate 0.1%

Structured Label Content

Indications and Usage (34067-9)

Temporarily Relieves Pain and Itching Associated with:

rashes due to poison ivy, poison oak, or poison sumac

insect bites

minor skin irritation

minor cuts

dries the oozing and weeping of poison ivy, poison oak and poison sumac

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only. Use only as directed.

Acoid contact with eyes and mucous membranes

Ask a doctor before using on children under 2 years of age.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

Section 51727-6 (51727-6)

SD Alcohol 38B 2.5%

Camphor

Diazolidinyl Usea

Fragrances

Glycerin

Hydroxypropyl Methylcellulose

Methylparaben

Polysorbate 80

Propylene Glycol

Propylparaben

Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

External Analgesic & Skin Protectant

Section 55106-9 (55106-9)

Pramoxine HCl 1%

Zinc Acetate 0.1%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Temporarily Relieves Pain and Itching Associated with: rashes due to poison ivy, poison oak, or poison sumac insect bites minor skin irritation minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac", "34068-7": "Adults and children 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion fo the affected area using cotton or soft cloth, not more than 3 to 4 times dialy as needed for comfort.", "34071-1": "For external use only. Use only as directed. Acoid contact with eyes and mucous membranes Ask a doctor before using on children under 2 years of age.", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)", "51727-6": "SD Alcohol 38B 2.5% Camphor Diazolidinyl Usea Fragrances Glycerin Hydroxypropyl Methylcellulose Methylparaben Polysorbate 80 Propylene Glycol Propylparaben Purified Water", "55105-1": "External Analgesic & Skin Protectant", "55106-9": "Pramoxine HCl 1% Zinc Acetate 0.1%"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information