FDA Label for Calamine
View Indications, Usage & Precautions
Calamine Product Label
The following document was submitted to the FDA by the labeler of this product Navarro Discount Pharmacies, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Calamine 8%
Pramoxine HCl 1%
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
* Please review the disclaimer below.