FDA Label for Leader Calamine Plus
View Indications, Usage & Precautions
Leader Calamine Plus Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. 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.
Warnings
- For external use only
- Avoid contact with eyes and mucous membranes
- Ask a doctor before using on children under 2 years of age
Otc - Active Ingredient
Calamine 8%
Pramoxine HCl 1%
Otc - Purpose
- Skin Protectant
- External Analgesic
Dosage & Administration
Adults and children 2 years of age and older: Shake well before using. CLeanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton of soft cloth, not more than 3 to 4 times daily as needed for comfort.
Children under 2 years of age: Consult a doctor before use.
Inactive Ingredient
SH Alcohol 38B 2.5%
Camphor
Diazolidinyl Urea
Fragrances
Glycerin
Hydroxypropyl Methylcellulose
Methylparaben
Polysorbate 80
Propylene Glycol
Propylparabaren
Purified water
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)
Indications & Usage
Uses:
temporarily relieves pain and itching associated with:
- rashes due to poison ivy, poison oak, or poison sumac
- insect bites
- minor skin irritation
- minor cuts
- ​dries the oozing and weeping of poison ivy, poison oak and poison sumac
Package Label.Principal Display Panel
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