Walmart Calaspray

Walmart Calaspray
SPL v2
SPL
SPL Set ID 027ed5ab-05ec-569f-e063-6394a90abbc3
Route
TOPICAL
Published
Effective Date 2023-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-26

Description

Pramoxine HCl 1%, 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.
  • avoid contact with broken skin,
  • do not inhale or ingest,
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if condition worsens, rash or irritation develops and lasts for more than 7 days or clears up and occurs again within a few days.

Indications and Usage

For the temporary relief of pain and itching associated with

  • rashes due to poison ivy, oak and sumac
  • insect bites
  • minor skin irritations
  • minor cuts
  • dries the oozing and weeping of poison ivy, oak, and sumac
Dosage and Administration

Adults and children 2 years or older: apply to affected are not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor. To apply to face, spray into palm of hand and gently apply.

Description

Pramoxine HCl 1%, Zinc acetate 0.1%

Section 50565-1

If product is swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 1%, Zinc acetate 0.1%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain and itching associated with

  • rashes due to poison ivy, oak and sumac
  • insect bites
  • minor skin irritations
  • minor cuts
  • dries the oozing and weeping of poison ivy, oak, and sumac
Dosage and Administration (34068-7)

Adults and children 2 years or older: apply to affected are not more than 3 to 4 times daily. Children under 2 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.
  • avoid contact with broken skin,
  • do not inhale or ingest,
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if condition worsens, rash or irritation develops and lasts for more than 7 days or clears up and occurs again within a few days.

Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 1%, Zinc acetate 0.1%


Advanced Ingredient Data


Raw Label Data

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