FDA Label for Dermagesic
View Indications, Usage & Precautions
Dermagesic Product Label
The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceuticals International Division. 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
Active Ingredients Purpose
Pramozine HCl .... 1% ............ Anesthetic/Analgesic
Zinc Oxide .........0.4% ............ Skin Protectant
Calamine ...........0.4% ............ Skin Protectant
Otc - Purpose
Purpose
Anesthetic/Analgesic
Skin Protectant
Indications & Usage
Uses
- for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritations
- dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Warnings
Warnings
- For external use only. Avoid contact with the eyes
- Not for Pediatric use
- Hypersensitivity to "caine" anesthetics
Otc - Do Not Use
Do not use
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
- on chicken pox
- on measles
- symptoms persist for more than 7 days or clear up and occur again within a few days
Ask a doctor before use
Stop use and ask a doctor if condition worsens or does not improve within 7 days
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions SHAKE WELL
- Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily
- Children under 2 years of age ask a doctor
- Do not use more often than directed
Inactive Ingredient
Inactive Ingredients: Glycerin, glyceryl stearate, PEG-100 Stearate, cetearyl alcohol, methylparaben, propylparaben, aloe barbadensis leaf juic (aloe vera), avena sativa (oat) kernel colloidal oatmeal, fregrance, hydroxypropyl methylcellulose, menthol, purified water
Otc - Questions
Questions: 1-866-595-5598
Package Label.Principal Display Panel
* Please review the disclaimer below.