Dch Calaspray Itch Relief Spray, Pramoxine Hcl 1%, Zinc Acetate 0.1%

Dch Calaspray Itch Relief Spray, Pramoxine Hcl 1%, Zinc Acetate 0.1%
SPL v2
SPL
SPL Set ID fda2afaf-3cd0-92b3-e053-6394a90a7493
Route
TOPICAL
Published
Effective Date 2021-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 g) Zinc Cation (0.1 g)
Inactive Ingredients
Citric Acid Monohydrate Ethylhexylglycerin Hypromelloses Camphor (synthetic) Alcohol Sodium Citrate Glycerin Water Polysorbate 40 Propylene Glycol Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-18
Description

Pramoxine HCl 2%, Zinc Acetate 0.1%

Medication Information

Warnings and Precautions

For external use only. Flammable--Keep away from fire or flame. Do not use on deep or puncture wounds, animal bites, or serious burns. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Indications and Usage

For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac. Dries the oozing and weeping of poison ivy, oak, and sumac.

Dosage and Administration

Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor. To apply to face, spray into palm of hand and gently apply.

Description

Pramoxine HCl 2%, Zinc Acetate 0.1%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Alcohol Denat., Camphor, Citric Acid, Ethylhexylglycerin, Fragrance, glycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polysorbate 40, Propylene Glycol, Sodium Citrate, Water.

Section 51945-4

Section 55105-1



Topical Analgesic, Skin Protectant

Section 55106-9

Pramoxine HCl 2%, Zinc Acetate 0.1%

Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac. Dries the oozing and weeping of poison ivy, oak, and sumac.

Dosage and Administration (34068-7)

Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor. To apply to face, spray into palm of hand and gently apply.

Warnings and Precautions (34071-1)

For external use only. Flammable--Keep away from fire or flame. Do not use on deep or puncture wounds, animal bites, or serious burns. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Alcohol Denat., Camphor, Citric Acid, Ethylhexylglycerin, Fragrance, glycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polysorbate 40, Propylene Glycol, Sodium Citrate, Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Topical Analgesic, Skin Protectant

Section 55106-9 (55106-9)

Pramoxine HCl 2%, Zinc Acetate 0.1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:00.177769 · Updated: 2026-03-14T23:06:16.981214