Otc - Active Ingredient
Salicylic Acid, 2%
Restoral
FDA Label NDC 69435-1805
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Peer Pharma Ltd. for the product Restoral (NDC 69435-1805). 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 package label.principal display panel, otc - active ingredient, otc - keep out of reach of children, otc - purpose, indications & usage, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Purpose
Uses
Relieves and helps prevent recurrence of skin itching
- irritation
- redness
- flaking
- scaling
due to psoriasis and seborrheic dermatitis
Indications & Usage
Directions
- apply to affected areas one to four times daily or as directed by a doctor
- massage a liberal amount of the product into skin until thoroughly absorbed
Dosage & Administration
Directions
- apply to affected areas one to four times daily or as directed by a doctor
- massage a liberal amount of the product into skin until thoroughly absorbed
Inactive Ingredient
Inactive ingredients
water, glyceryl stearate, PEG-100 stearate, glycerin, niacinamide, calendula officinalis flower oil, cannabis sativa seed oil, cetyl alcohol, butyrospermum parkii (shea butter), petrolatum, allantoin, steareth-21, tocopheryl acetate (vitamin E), lavandula angustifolia (lavender) oil, xanthan gum, dipotassium glycyrrhizate, aloe barbadensis leaf juice, triethanolamine, bisabolol, disodium EDTA, maris sal (dead sea mineral water).
* Please review the disclaimer below.
