SHEFFIELD ADVANCED SCAR GEL- advanced scar gel gel 
Sheffield Pharmaceuticals LLC

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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Drug Facts

Active ingredients 

Allantion 0.5%

Purpose

Skin Protectant 

Uses

Temporarily protects and helps chapped or cracked skin

Warnings

For external use only

When using this product 

  • do not get into eyes 

Stop Use and Ask a Doctor if

  • condition worsens
  • symptoms last for more than 7 days or clears up and occur again within a few days 

Do Not Use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Apply as needed 

Other information

Inactive ingredient

Water (Purified), PEG 300, Allium Cepa (Onion) Bulb Extract, Xanthan Gum, Alcohol, Methylparaben, Sorbic Acid, Panthenol, Sodium Hyaluronate, Fragrance

Principal Display Panel –Tube

Sheffield          NDC 11527-72-07

Advanced Scar Gel 

0.5% Allantoin 

NET WT. 0.70 oz (20g)

2720004-Sheffield_AdvancedScarGel_TUBE.jpg

Principal Display Panel – Carton

Sheffield          NDC 11527-725-07

Advance Scar Gel 

Skin Protectant

NET WT. 0.70 oz (20g)

500077-Sheffield_AdvancedScarGel_Carton.jpg

SHEFFIELD ADVANCED SCAR GEL 
advanced scar gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-725
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
ONION (UNII: 492225Q21H)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Sorbic Acid (UNII: X045WJ989B)  
PANTHENOL (UNII: WV9CM0O67Z)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-725-071 in 1 CARTON10/14/2021
120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/14/2021
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-725)

Revised: 5/2022
Document Id: ccb5a399-aca6-4dbd-b1a6-eb4a850cbbe5
Set id: ab78b946-81ed-442c-a167-26c26c7fe8a1
Version: 1
Effective Time: 20220509
 
Sheffield Pharmaceuticals LLC