FDA Label for Peviderm Pramoxine Hydrocholride 1%
View Indications, Usage & Precautions
Peviderm Pramoxine Hydrocholride 1% Product Label
The following document was submitted to the FDA by the labeler of this product Stratus Pharmaceuticals Inc. 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.
Other
Drug Facts
Distributed by:
STRATUS
PHARMACEUTICALS INC
Miami, Florida 33186
Active Ingredient
Pramoxine Hydrochloride 1%
Purpose
External Analgesic
Uses
- for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac
Warnings
for external use only
When Using This Product
- avoid contact with eyes
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact Poison Control Center immediately
Directions
- to open, hold cap tightly and turn pump counter-clockwise
- apply to affected area not more than 3 to 4 times daily
- consult a doctor
Adults and children 2 years of age and older:
Children under 2 years of age:
Other Information
- Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]
Inactive Ingredients
Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Isopropyl Myristate, Petrolatum, PEG-8 Stearate, PEG-100 Stearate, Purified Water, Sodium Hydroxide, Stearic Acid.
Questions Or Comments?
Call us at 1-800-442-7882
Principal Display Panel - 222 Ml Bottle Box
NDC 58980-913-80
Steroid-Free & Fragrance-Free
PEVIDERM™
PRAMOXINE HYDROCHLORIDE 1%
ITCH RELIEF FOR SENSITIVE SKIN
EXTERNAL
ANALGESIC LOTION
Moisturizes and gently relieves
itch associated with:
Eczema and
Dry Sensitive Skin
Net 7.5 fl oz (222 mL)
* Please review the disclaimer below.
