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CVS Calamine Plus
Drug Facts
Cvs Calamine Plus Roll On Lotion
FDA Label NDC 51316-420
11 label sections · Submitted to the FDA by Cvs Pharmacy · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Calamine Plus Roll On (NDC 51316-420). 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 other, active ingredient, purpose, use, warnings, avoid contact, 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
Active Ingredient
Calamine 8%
Pramoxine HCl 1%
Purpose
Skin Protectant
External Analgesic
Use
Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, poison sumac or other minor skin irritations.
Warnings
For external use only. Use only as directed.
Avoid Contact
with eyes and mucous membranes
Stop Use And Ask A Doctor If
- condition worsens
- symptoms last for more than 7 days, or clear up and occur again within a few days.
Keep Out Of Reach Of Children.
- In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- Adults and children 2 years and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area no more than 3 to 4 times daily as needed for comfort.
- Children under 2 years of age: Do not use, consult a doctor.
Other Information
- store at room temperature 15 o – 30 oC (59 o – 86 oF)
Inactive Ingredient
SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.
* Please review the disclaimer below.
