FDA Label for Sunmark Caldiphen
View Indications, Usage & Precautions
Sunmark Caldiphen Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services. 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.
Active Ingredients
Calamine 8%
Pramoxine HCl 1%
Purpose
Skin Protectant
External analgesic
Uses
Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.
Warnings
For external use only. Use only as directed.
When using this product. Avoid contact with eyes and moucous membranes.
Stop Ue And Ask A Doctor If
condition worsens. Symptoms last for more than 7days or clear up and occur again whitin a few days.
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately.
Directions
Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.
Children under 2 yrs. of age. Consult a doctor before use.
Inactive Ingredients
SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.
Other Information
Store at room temperature 15-30C (59-86F)
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