Active Ingredient
Pramoxine Hydrochloride 1%
Sarna Lotion
FDA Label NDC 0316-0230
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Crown Laboratories for the product Sarna (NDC 0316-0230). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Do Not Use
- in the eyes
- over large areas of the body
- for prolonged periods
When Using This Product
- avoid contact with eyes
- if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Stop Use And Ask A Doctor If
- redness, irritation, swelling, or pain persists or increases.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- To open, hold cap and turn pump clockwise.
- 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: do not use, consult a doctor.
Other Information
- store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Beta-Glucan, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Citric Acid, Dimethicone, Ethylhexylglycerin, Glyceryl Stearate, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Citrate, Sodium Hydroxide, Squalane, Stearic Acid, Tocopherol, Water
Sarna Sensitive Principal Display Panel
#1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND
Sarna
Pramoxine Hydrochloride 1%
External Analgesic Lotion
Steroid Free
SENSITIVE
ANTI-ITCH LOTION
- Eases itch associated with minor skin irritations
- Soothes and conditions with Aloe, Squalene, and Jojoba Oil
- Hypoallergenic
NET WT. 7.5fl oz (222 ml)
* Please review the disclaimer below.
