RESTORAL- salicylic acid cream cream 
Peer Pharma Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Restoral

Restoral OTC

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).

RESTORAL 
salicylic acid cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1805
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 150 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69435-1805-1150 mL in 1 CONTAINER; Type 0: Not a Combination Product06/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/14/2018
Labeler - Peer Pharma Ltd. (514678390)
Registrant - Peer Pharma Ltd. (514678390)
Establishment
NameAddressID/FEIBusiness Operations
Peer Pharma Ltd.514678390manufacture(69435-1805)

Revised: 6/2018
Document Id: 6e9bb6cf-28d7-7e2e-e053-2a91aa0ae7fd
Set id: 6e9bb6aa-2b24-84fb-e053-2991aa0ae6ef
Version: 1
Effective Time: 20180614
 
Peer Pharma Ltd.