Active Ingredients
Calamine 8%
Pramoxine HCI 1%
Calamine Plus Pramoxine Hcl Aerosol, Spray
FDA Label NDC 41250-235
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc. for the product Calamine Plus Pramoxine Hcl (NDC 41250-235). 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, flammable:, when using this product, stop use and ask a doctor if, keep out of the 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 temperatures above 120°F. Intentional misuse by deliberately 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
- condition worsens
- symptoms last more than 7 days or clear up and occur again in a few days
Keep Out Of The 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 to affected area not more than 3 to 4 times daily
- cleanse the skin with soap and water
- let dry before use
- children under 2 years of age: consult a doctor
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
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meijer
NO-RUB
calamine plus spray
Calamine Pramoxine HCI
Skin Protectant
External Analgesic
SHAKE WELL BEFORE USE
Relieves itching from poison ivy, oak & sumac, & insect bites
Soothes minor skin irritations & cuts
NET WT 4.1 OZ (116 g)
* Please review the disclaimer below.
