DERMACHANGE SCAR- allantoin gel

Dermachange Scar by

Drug Labeling and Warnings

Dermachange Scar by is a Otc medication manufactured, distributed, or labeled by Private Label Beauty and Wellness, Derma Care Research Labs, LLC, Derma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Allantoin 0.5%

PURPOSE

Skin Protectant.

DOSAGE & ADMINISTRATION

Temporarily protects and helps relieve chapped or cracked skin.

WARNINGS

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

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

INDICATIONS & USAGE

Apply as needed.

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMACHANGE SCAR 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83520-297
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83520-297-00	1 in 1 BOX	02/27/2024
1		19.8 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	02/27/2024

Labeler - Private Label Beauty and Wellness (035014854)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs		116817470	manufacture(83520-297)