Active Ingredients
Calamine 8%
Pramoxine HCl 1%
Sunmark Caldiphen Lotion
FDA Label NDC 49348-337
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services for the product Sunmark Caldiphen (NDC 49348-337). 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, stop ue and ask a doctor if, keep out of reach of children., directions, inactive ingredients, 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
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)
Principal Display Panel
Label
Label (L040096074 Sm Caldyphen Lotion)
* Please review the disclaimer below.
