Walgreens Advanced Scar Gel: Package Insert and Label Information

WALGREENS ADVANCED SCAR GEL- allantoin gel
Walgreens Company

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.

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

Principal Display Panel – Tube

Walgreens NDC 0363-2312-07

Advanced Scar Gel

0.5% Allantoin

NET WT. 0.70 oz (20g)

Principal Display Panel – Carton

Principal Display Panel – Carton

Walgreens NDC 0363-2312-07

Advance Scar Gel

Skin Protectant

NET WT. 0.70 oz (20g)

WALGREENS ADVANCED SCAR GEL advanced scar gel gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-2312 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (ALLANTOIN) ALLANTOIN 5 mg in 1 g

Inactive Ingredients Ingredient Name Strength WATER POLOXAMER 407 ONION XANTHAN GUM ALCOHOL METHYLPARABEN Sorbic Acid PANTHENOL HYALURONATE SODIUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0363-2312-07 1 TUBE in 1 CARTON contains a TUBE 1 20 g in 1 TUBE This package is contained within the CARTON (0363-2312-07)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/26/2019

Labeler — Walgreens Company (008965063)

Registrant — Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE (0363-2312)

Revised: 07/2020 Walgreens Company