FDA Label for Calamine Clear
View Indications, Usage & Precautions
Calamine Clear 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.
Otc - Active Ingredient
Pramoxine HCl 1%
Zinc Acetate 0.1%
Otc - Purpose
External Analgesic & Skin Protectant
Indications & Usage
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
Warnings
For external use only. Use only as directed.
Acoid contact with eyes and mucous membranes
Ask a doctor before using on children under 2 years of age.
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)
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 fo the affected area using cotton or soft cloth, not more than 3 to 4 times dialy as needed for comfort.
Inactive Ingredient
SD Alcohol 38B 2.5%
Camphor
Diazolidinyl Usea
Fragrances
Glycerin
Hydroxypropyl Methylcellulose
Methylparaben
Polysorbate 80
Propylene Glycol
Propylparaben
Purified Water
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