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 –Tube
(click image for full-size original)
Principal Display Panel –Tube
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Principal Display Panel – Carton

Principal Display Panel – Carton

Walgreens NDC 0363-2312-07

Advance Scar Gel

Skin Protectant

NET WT. 0.70 oz (20g)

Principal Display Panel – Carton
(click image for full-size original)
Principal Display Panel – Carton
(click image for full-size original)
Principal Display Panel – Carton
(click image for full-size original)
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

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