FDA Label for Sunmark Phenolated Calamine
View Indications, Usage & Precautions
Sunmark Phenolated Calamine Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. 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 Ingredient
Calamine 8%
Zinc Oxide 8%
Liquefied Phenol
Purpose
Skin Protectant
Skin Protectant
Topical Analgesic
Uses
Dries the oozing and weeping and temporarily pain and itching of poison ivy, poison oak, and poison sumac, or other minor skin irritations
Warnings
- For external use only. Use only as directed.
- Avoid contact with eyes and mucous membranes.
- Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas.
- If applied to fingers or toes do not bandage.
Ask A Doctor
before using on children under 2 years of age.
When using this product. Discontinue use if condition worsen or does not improve within 7 days and consult a doctor.
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek professional assistance or contact a poison Control Center immediately.
Directions (Shake Well Before Using)
Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort.
Children under 2 years of age: Consult a doctor before use.
Other Information.
Store at room temperature 15-30C (59-86F)
Inactive Ingredients.
Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.
Principal Display Panel
Label
* Please review the disclaimer below.