advanced scar gel

SPL v3

SPL

SPL Set ID 86c215fe-aad4-45d1-bdb7-cde00a115c5c

Route

topical

Published

Effective Date 2022-03-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

allantoin (5 mg)

Inactive Ingredients

water poloxamer 407 onion xanthan gum alcohol methylparaben sorbic acid panthenol hyaluronate sodium

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2020-08-15

Purpose

Skin Protectant

Description

Drug Facts

Medication Information

Warnings

For external use only

Uses

Temporarily protects and helps chapped or cracked skin

Purpose

Skin Protectant

Directions

Apply as needed

Other Information

Store at room temperature

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Do Not Use On

deep or puncture wounds
animal bites
serious burns

Inactive Ingredient

Water (Purified), PEG 300, Allium Cepa (Onion) Bulb Extract, Xanthan Gum, Alcohol, Methylparaben, Sorbic Acid, Panthenol, Sodium Hyaluronate, Fragrance

Active Ingredients

Allantion 0.5%

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

Principal Display Panel –tube

Principal Display Panel – Tube

Target Up & Up NDC 11637-0725-27

Advanced Scar Gel

0.5% Allantoin

NET WT. 0.70 oz (20g)

Principal Display Panel – Carton

Principal Display Panel – Carton

Target Up & Up NDC 11673-0725-27

Advance Scar Gel

Skin Protectant

NET WT. 0.70 oz (20g)

Structured Label Content

Warnings

For external use only

Uses

Temporarily protects and helps chapped or cracked skin

Purpose

Skin Protectant

Directions

Apply as needed

Other Information (Other information)

Store at room temperature

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Do Not Use On (Do Not Use on)

deep or puncture wounds
animal bites
serious burns

Inactive Ingredient (Inactive ingredient)

Water (Purified), PEG 300, Allium Cepa (Onion) Bulb Extract, Xanthan Gum, Alcohol, Methylparaben, Sorbic Acid, Panthenol, Sodium Hyaluronate, Fragrance

Active Ingredients (Active ingredients )

Allantion 0.5%

When Using This Product (When using this product )

do not get into eyes

Stop Use and Ask A Doctor If (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

Principal Display Panel –tube (Principal Display Panel –Tube)

Principal Display Panel – Tube

Target Up & Up NDC 11637-0725-27

Advanced Scar Gel

0.5% Allantoin

NET WT. 0.70 oz (20g)

Principal Display Panel – Carton

Principal Display Panel – Carton

Target Up & Up NDC 11673-0725-27

Advance Scar Gel

Skin Protectant

NET WT. 0.70 oz (20g)

Advanced Ingredient Data

[{"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ONION", "unii": "492225Q21H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sorbic Acid", "unii": "X045WJ989B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily protects and helps chapped or cracked skin", "42229-5": "Drug Facts", "50565-1": "Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.", "Purpose": "Skin Protectant ", "Warnings": "For external use only", "Directions": "Apply as needed ", "Do Not Use on": "deep or puncture wounds animal bites serious burns", "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", "Active ingredients ": "Allantion 0.5%", "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 ", "Principal Display Panel –Tube": "Principal Display Panel – Tube Target Up & Up NDC 11637-0725-27 Advanced Scar Gel 0.5% Allantoin NET WT. 0.70 oz (20g)", "Principal Display Panel – Carton": "Principal Display Panel – Carton Target Up & Up NDC 11673-0725-27 Advance Scar Gel Skin Protectant NET WT. 0.70 oz (20g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.013031 · Updated: 2026-03-14T23:05:15.511736