RITE AID SCAR- allantoin 0.5% gel 
Rite Aid

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.

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Rite Aid Scar Gel

Allantoin 0.5%

Skin Protectant.

Temporarily protects and helps relieve chapped or cracked skin.

For external use only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Do not use on deep or puncture wounds, animal bites, and serious burns.

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

Apply as needed.

Water, Alcohol Denat., PEG-4, Propylene Glycol, Xanthan Gum, Allium Cepa (Onion) Bulk Extract, Panthenol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Tocopherol, Glycerin, Juglans Nigra (Black Walnut) Leaf Extract, Ethylhexylglycerin, Benzyl Alcohol, Fragrance.

Carton

RITE AID SCAR 
allantoin 0.5% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1297
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PANTHENOL (UNII: WV9CM0O67Z)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ONION (UNII: 492225Q21H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BLACK WALNUT (UNII: 02WM57RXZJ)  
CHAMOMILE (UNII: FGL3685T2X)  
CUCUMBER (UNII: YY7C30VXJT)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1297-11 in 1 BOX09/15/2022
119.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01609/15/2022
Labeler - Rite Aid (014578892)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(11822-1297)

Revised: 6/2023
Document Id: fd152c8f-6df6-1236-e053-6394a90a865d
Set id: fd152c8f-6df5-1236-e053-6394a90a865d
Version: 1
Effective Time: 20230601
 
Rite Aid