Top Care Calaclear Lotion

Top Care Calaclear Lotion
SPL v5
SPL
SPL Set ID 8dce8817-b905-4064-e053-2995a90a071e
Route
TOPICAL
Published
Effective Date 2019-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg) Zinc Cation (1 mg)
Inactive Ingredients
Propylene Glycol Propylparaben Water Glycerin Camphor (natural) Alcohol Diazolidinyl Urea Hypromellose, Unspecified Methylparaben Polysorbate 80

Identifiers & Packaging

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

Description

Pramoxine HCl 1% Zing Acetate 0.1%


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 children under 2 years of age.

When using this product. Discontinue use if

condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor.

Keep out of reach of children.

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

Indications and Usage

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

Dosage and Administration

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

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

Description

Pramoxine HCl 1% Zing Acetate 0.1%

Section 50565-1

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Section 51727-6

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, 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%

Zing Acetate 0.1%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily 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 children under 2 years of age.

When using this product. Discontinue use if

condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor.

Keep out of reach of children.

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

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)

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, 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%

Zing Acetate 0.1%


Advanced Ingredient Data


Raw Label Data

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