Active Ingredients
Calamine 8%
Pramoxine HCl 1%
Calamine
FDA Label NDC 59970-075
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Navarro Discount Pharmacies, Llc for the product Calamine (NDC 59970-075). 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 active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Topical analgesic
Uses
temporarily relieves pain and itching associated with:
- rashes due to poison ivy, poison oac or poison sumac
- insect bites
- minor skin irritation
- minor cuts
dries the oozing and weeping of poison ivy, poison oak and poison sumac
Warnings
For external use only.
When Using This Product
do not get into eyes
Stop Use And Ask A Doctor If
- condition worsens or does not improve within 7 days
- symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- shake well before use
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
Other Information
- store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, zanthan gum
Package Label
Image Of Bottle Label (Calamine.nav.bottle)
* Please review the disclaimer below.
