DGH ADVANCED FORMULA SCAR SKIN PROTECTANT- allantoin gel

DGH Advanced Formula Scar Skin Protectant by

Drug Labeling and Warnings

DGH Advanced Formula Scar Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Dolgencorp Inc, Garcoa, Inc., Sigan Industries INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Allantoin 0.5%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin.

Warnings

For external use only.

When using this product

• ⬥ Do not get into eyes

Stop use and consult a doctor if

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

Do not use on

• ⬥ Deep or puncture wounds
• ⬥ animal bites
• ⬥ serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

• ⬥ apply as needed

Other information

store at room temperature.

Inactive ingredients

water, PEG-4, glycerin, alcohol denat., propylene glycol, xanthan gum, allium cepa (onion) bulk extract, soy lecithin, panthenol, sodium hyaluronate, carbomer, sodium hydroxide, phenoxyethanol, ethylhexylglycerin, fragrance

Questions or comments?

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SPL UNCLASSIFIED SECTION

DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

DG™ | health

Compare to the
active ingredient
of Mederma®
Advanced Scar Gel*

Advanced Formula

Scar Gel

Skin Protectant

Allantoin 0.5% / Skin Protectant

• Helps to reduce the appearance of
  OLD and NEW scars resulting from
  acne, burns, injury, surgery
• 1x Daily Skin Protectant

NET WT 1.76 OZ (50 g)

INGREDIENTS AND APPEARANCE

DGH ADVANCED FORMULA SCAR SKIN PROTECTANT 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-540
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)
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
Glycerin (UNII: PDC6A3C0OX)
Alcohol (UNII: 3K9958V90M)
Propylene Glycol (UNII: 6DC9Q167V3)
Xanthan Gum (UNII: TTV12P4NEE)
Onion (UNII: 492225Q21H)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
Panthenol (UNII: WV9CM0O67Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Sodium Hydroxide (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-540-01	1 in 1 CARTON	12/09/2021
1		50 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 FINAL	part347	12/09/2021

Labeler - Dolgencorp Inc (068331990)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(55910-540)