Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID bab404f0-2f7a-4bac-b053-cbdc81c029b5
Route
TOPICAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (5 mg)
Inactive Ingredients
Aloe Vera Leaf Sheanut Oil Caprylyl Glycol Caprylyl/capryl Oligoglucoside Citric Acid Monohydrate Glycerin Soybean Oil Sunflower Oil Methylpropanediol Panthenol Pantolactone, (r)- Phenoxyethanol Polyisobutylene (1000 Mw) Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Tocopherol Water Sorbitan Monooleate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-17

Description

Allantoin 0.5%......Skin Protectant

Purpose

Allantoin 0.5%......Skin Protectant


Medication Information

Purpose

Allantoin 0.5%......Skin Protectant

Description

Allantoin 0.5%......Skin Protectant

Uses

Temporarily protects minor: ●cuts

●scrapes ●burns ■helps prevent and temporarily

protects and helps relieve chafed, 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 more than 7 days or clear up and occur again within a few days.

Do not use on ■Deep or puncture wounds

■Animal bites ■Serious burns

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

ALOE BARBADENSIS LEAF JUICE POWDER, BUTYROSPERMUM PARKII (SHEA) OIL, CAPRYLYL GLYCOL, CAPRYLYL/CAPRYL GLUCOSIDE, CITRIC ACID, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYLPROPANEDIOL, PANTHENOL, PANTOLACTONE, PHENOXYETHANOL, POLYISOBUTENE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, TOCOPHEROL, WATER

Questions Or Comments?

1-866-735-4137

Active Ingredients......purpose

Allantoin 0.5%......Skin Protectant

Principle Display Panel 16 Oz Jar

NEW LOOK

Cetaphil®

Soothing Gel Cream

0.5% Allantoin Skin Protectant

Dry, Irritated Skin

Fast absorbing gel-cream

helps relieves and prevent irritated skin.

Aloe Vera, Vitamin B5



Dermatologist Recommended

Sensitive Skin





         

NET WT 16 OZ (453 g)

Distributed By:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their respective owners.



Made in Canada.



cetaphil.com

P55450-3


Structured Label Content

Uses

Temporarily protects minor: ●cuts

●scrapes ●burns ■helps prevent and temporarily

protects and helps relieve chafed, 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 more than 7 days or clear up and occur again within a few days.

Do not use on ■Deep or puncture wounds

■Animal bites ■Serious burns

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

ALOE BARBADENSIS LEAF JUICE POWDER, BUTYROSPERMUM PARKII (SHEA) OIL, CAPRYLYL GLYCOL, CAPRYLYL/CAPRYL GLUCOSIDE, CITRIC ACID, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYLPROPANEDIOL, PANTHENOL, PANTOLACTONE, PHENOXYETHANOL, POLYISOBUTENE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, TOCOPHEROL, WATER

Questions Or Comments? (Questions or comments?)

1-866-735-4137

Active Ingredients......purpose (Active ingredients......Purpose)

Allantoin 0.5%......Skin Protectant

Principle Display Panel 16 Oz Jar (PRINCIPLE DISPLAY PANEL - 16 OZ jar)

NEW LOOK

Cetaphil®

Soothing Gel Cream

0.5% Allantoin Skin Protectant

Dry, Irritated Skin

Fast absorbing gel-cream

helps relieves and prevent irritated skin.

Aloe Vera, Vitamin B5



Dermatologist Recommended

Sensitive Skin





         

NET WT 16 OZ (453 g)

Distributed By:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their respective owners.



Made in Canada.



cetaphil.com

P55450-3


Advanced Ingredient Data


Raw Label Data

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