RESTORAL- salicylic acid cream cream

Restoral by

Drug Labeling and Warnings

Restoral by is a Otc medication manufactured, distributed, or labeled by Peer Pharma Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Salicylic Acid, 2%

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses
Relieves and helps prevent recurrence of skin itching

• irritation
• redness
• flaking
• scaling

due to psoriasis and seborrheic dermatitis

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

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 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).

INGREDIENTS AND APPEARANCE

RESTORAL 
salicylic acid cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1805
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	3 g  in 150 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARETH-21 (UNII: 53J3F32P58)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
SHEA BUTTER (UNII: K49155WL9Y)
PETROLATUM (UNII: 4T6H12BN9U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
TROLAMINE SALICYLATE (UNII: H8O4040BHD)
LEVOMENOL (UNII: 24WE03BX2T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CETYL ALCOHOL (UNII: 936JST6JCN)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
ALLANTOIN (UNII: 344S277G0Z)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1805-1	150 mL in 1 CONTAINER; Type 0: Not a Combination Product	06/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/14/2018

Labeler - Peer Pharma Ltd. (514678390)

Registrant - Peer Pharma Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharma Ltd.		514678390	manufacture(69435-1805)