SHEFFIELD ADVANCED SCAR GEL- advanced scar gel gel

Sheffield Advanced Scar Gel by

Drug Labeling and Warnings

Sheffield Advanced Scar Gel by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• Store at room temperature 

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)

Principal Display Panel – Carton

Sheffield          NDC: 11527-725-07

Advance Scar Gel 

Skin Protectant

NET WT. 0.70 oz (20g)

INGREDIENTS AND APPEARANCE

SHEFFIELD ADVANCED SCAR GEL 
advanced scar gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-725
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-725-07	1 in 1 CARTON	10/14/2021
1		20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/14/2021

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(11527-725)