Active Ingredient
Calamine 8%
Pramoxine HCl 1%
Calamine Plus Pramoxine Hcl
FDA Label NDC 41520-184
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foodhold Usa for the product Calamine Plus Pramoxine Hcl (NDC 41520-184). 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 ingredient, purpose, uses, warnings, flammable:, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
External analgesic
Uses
temporarily relieves pain and itching associated with:
- insect bites
- rashes
- minor skin irritations
- minor cuts
- dries the oozing and weeping of poison ivy, poison oak and poison sumac
Warnings
For external use only.
Flammable:
Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by delibrately concentrating and inhaling contents can be harmful or fatal.
When Using This Product
- do not get into eyes
- ask a doctor before using on children under 2 years of age
Stop Use And Ask A Doctor If
- conditions worsens
- symptoms last more than 7 days or clear up and occur again in 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 using
- adults and children 2 years of age and older: apply as needed to the affected area, not more than 3 or 4 times daily
- cleanse the skin with soap and water
- let dry before use
- children under 2 years of age: consult a doctor
Other Information
store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate
Questions?
Call 1-866-964-0939
Principal Display Panel
CareOne
NO-RUB CALAMINE SPRAY
Calamine 8%/ Skin Protectant
Pramoxine HCl 1%/ External Analgesic
TEMPORARILY RELIEVES ITCHING FROM POISON IVY, OAK & SUMAC, AND INSECT BITES
SOOTHES MINOR SKIN IRRITATIONS AND CUTS
Shake well before use
NET WT 4.1 OZ (116g)
* Please review the disclaimer below.
