SKINCEUTICALS ADVANCED SCAR CONTROL SKIN PROTECTANT- allantoin gel

SkinCeuticals Advanced Scar Control Skin Protectant by

Drug Labeling and Warnings

SkinCeuticals Advanced Scar Control Skin Protectant by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Beauty Manufacturing Solutions Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Allantoin 0.5%

Purpose

Skin protectant

Uses

temporarily protects minor:

• cuts
• scrapes
• burns

Warnings

For external use only

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

When using this product

do not get into eyes

Stop use and ask a doctor if

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

● apply as needed

Inactive ingredients

dimethicone, dimethicone crosspolymer, helianthus annuus (sunflower) seed oil unsaponifiables, silica silylate, acrylates/dimethicone copolymer, jojoba esters, helianthus annuus (sunflower) seed wax, acacia decurrens flower wax, polyglycerin-3

Questions or comments?

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKINCEUTICALS ADVANCED SCAR CONTROL SKIN PROTECTANT 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-783
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 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-783-01	1 in 1 CARTON	06/01/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-783-02	4 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2021
3	NDC: 49967-783-03	1 in 1 CARTON	06/01/2021
3		50 mL in 1 BOTTLE; 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	06/01/2021

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(49967-783)