Otc - Active Ingredient
Pramoxine HCl 1%, Zinc acetate 0.1%
Equate Calaspray
FDA Label NDC 79903-212
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc for the product Equate Calaspray (NDC 79903-212). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic / Skin protectant
Indications & 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
Warnings
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.
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & 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.
Inactive Ingredient
Alcohol denat., camphor, citric acid, ethylhexylglycerin, fragrance, glycerin, hydroxypropyl methylcellulose, phenoxyethanol, polysorbate 40, propylene glycol, sodium citrate, water.
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