Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 38254e03-3716-4e45-86b7-06430ebadc86
Route
TOPICAL
Published
Effective Date 2022-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (5 mg)
Inactive Ingredients
Sheanut Oil Calendula Officinalis Flower 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 2020-02-03

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 ■Helps protect from the drying

effects of wind and cold weather.

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

BUTYROSPERMUM PARKII (SHEA) OIL, CALENDULA OFFICINALIS FLOWER EXTRACT, CAPRYLYL/CAPRYL GLUCOSIDE, CAPRYLYL GLYCOL, 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

Distributed By:

Galderma Laboratories, L.P.

Fort Worth, TX 76177 USA

All trademarks are the property of their respective owners

Made in Canada

cetaphil.com

Active Ingredients......purpose

Allantoin 0.5%......Skin Protectant

Principle Display Panel 6 Oz Tube

#1 Doctor Recommended

Sensitive Skincare Brand



Cetaphil®

baby

Soothe & Protect

Cream

with Allantoin -

Skin Protectant

         

Baby's Sensitive Skin

Protects baby's delicate skin 

and prevents dry, chafed or

cracked skin

Soothing calendula





(SEAL) Dermatologist tested



NET WT 6 oz (170 g)


Structured Label Content

Uses

Temporarily protects minor: ●cuts

●scrapes ●burns ■helps prevent and temporarily

protects and helps relieve chafed, chapped or

cracked skin ■Helps protect from the drying

effects of wind and cold weather.

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

BUTYROSPERMUM PARKII (SHEA) OIL, CALENDULA OFFICINALIS FLOWER EXTRACT, CAPRYLYL/CAPRYL GLUCOSIDE, CAPRYLYL GLYCOL, 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

Distributed By:

Galderma Laboratories, L.P.

Fort Worth, TX 76177 USA

All trademarks are the property of their respective owners

Made in Canada

cetaphil.com

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

Allantoin 0.5%......Skin Protectant

Principle Display Panel 6 Oz Tube (PRINCIPLE DISPLAY PANEL - 6 oz tube)

#1 Doctor Recommended

Sensitive Skincare Brand



Cetaphil®

baby

Soothe & Protect

Cream

with Allantoin -

Skin Protectant

         

Baby's Sensitive Skin

Protects baby's delicate skin 

and prevents dry, chafed or

cracked skin

Soothing calendula





(SEAL) Dermatologist tested



NET WT 6 oz (170 g)


Advanced Ingredient Data


Raw Label Data

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