Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5140754e-5db0-470f-adfd-de02b184880b
Route
TOPICAL
Published
Effective Date 2023-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (715 mg)
Inactive Ingredients
Cetearyl Ethylhexanoate Shea Butter Yellow Wax Microcrystalline Wax .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01

Description

Petrolatum 71.5%......Skin Protectant

Purpose

Petrolatum 71.5%......Skin Protectant


Medication Information

Purpose

Petrolatum 71.5%......Skin Protectant

Description

Petrolatum 71.5%......Skin Protectant

Uses

● temporarily protects minor:

   ● cuts ● scrapes ● burns

● temporary protects and helps relieve chafed, chapped or cracked skin

● helps prevent and protect from the drying effects of wind and cold weather

● helps treat and prevent diaper rash

● protects chafed skin associated with diaper rash and helps protect from wetness



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

● for diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. 

Questions?

1-866-735-4137

Distributed By:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

Made in Canada

cetaphil.com

P57538-0

Inactive Ingredients

CETEARYL ETHYLHEXANOATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, BEESWAX, MICROCRYSTALLINE WAX, TOCOPHERYL ACETATE (VITAMIN E ACETATE)

Active Ingredient......purpose

Petrolatum 71.5%......Skin Protectant

Principle Display Panel 12 Oz (340 G) Jar

Cetaphil®

baby

Healing

Ointment



Baby's Sensitive Skin

Skin Protectant          

NATIONAL ECZEMA

ASSOCIATION LOGO



NET WT 12 OZ (340 g)




Structured Label Content

Uses

● temporarily protects minor:

   ● cuts ● scrapes ● burns

● temporary protects and helps relieve chafed, chapped or cracked skin

● helps prevent and protect from the drying effects of wind and cold weather

● helps treat and prevent diaper rash

● protects chafed skin associated with diaper rash and helps protect from wetness



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

● for diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. 

Questions?

1-866-735-4137

Distributed By:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

Made in Canada

cetaphil.com

P57538-0

Inactive Ingredients

CETEARYL ETHYLHEXANOATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, BEESWAX, MICROCRYSTALLINE WAX, TOCOPHERYL ACETATE (VITAMIN E ACETATE)

Active Ingredient......purpose (Active ingredient......Purpose)

Petrolatum 71.5%......Skin Protectant

Principle Display Panel 12 Oz (340 G) Jar (PRINCIPLE DISPLAY PANEL - 12 OZ (340 g) jar)

Cetaphil®

baby

Healing

Ointment



Baby's Sensitive Skin

Skin Protectant          

NATIONAL ECZEMA

ASSOCIATION LOGO



NET WT 12 OZ (340 g)




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)