Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 27d74e0f-8359-4c59-bf7f-acade7f4545c
Route
TOPICAL
Published
Effective Date 2023-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Medium-chain Triglycerides Hydrogenated Castor Oil Lactic Acid, Unspecified Form Methoxy Peg-22/dodecyl Glycol Copolymer Methylparaben Mineral Oil Ceresin Peg-7 Hydrogenated Castor Oil Propylparaben Sodium Lactate Sorbitan Isostearate Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01

Description

Dimethicone 2%......Skin protectant

Purpose

Dimethicone 2%......Skin protectant


Medication Information

Purpose

Dimethicone 2%......Skin protectant

Description

Dimethicone 2%......Skin protectant

Uses

● helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin

● temporary protects minor:

   ● cuts ● scrapes ● burns

● helps prevent and 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 generously to affected area as needed

Inactive Ingredients

CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED CASTOR OIL, LACTIC ACID, METHOXY PEG-22/DODECYL GLYCOL COPOLYMER, METHYLPARABEN, MINERAL OIL, OZOKERITE, PEG-2 HYDROGENATED CASTOR OIL, PEG-7 HYDROGENATED CASTOR OIL, PROPYLPARABEN, SODIUM LACTATE, SORBITAN ISOSTEARATE, UREA, WATER

Questions Or Comments?

1-866-735-4137

Distributed By:

Galderma Laboratories, L.P.

Dallas, TX 75201

All trademarks are the property of their respective owners.

Made in Canada

cetaphil.com

Active Ingredients......purpose

Dimethicone 2%......Skin protectant

Principle Display Panel 16 Fl Oz Pump Label

Dermatologist Recommended

For Sensitive Skin



Cetaphil®



Cracked Skin Repair Lotion

Skin Protectant Dimethicone

Rough, Cracked Sensitive Skin

Daily use lotion is designed to hydrate

and restore rough skin and prevent

cracked skin from coming back.



Urea

5 skin sensitivity signs

16 FL OZ (473 mL)



P56383-1


Structured Label Content

Uses

● helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin

● temporary protects minor:

   ● cuts ● scrapes ● burns

● helps prevent and 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 generously to affected area as needed

Inactive Ingredients

CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED CASTOR OIL, LACTIC ACID, METHOXY PEG-22/DODECYL GLYCOL COPOLYMER, METHYLPARABEN, MINERAL OIL, OZOKERITE, PEG-2 HYDROGENATED CASTOR OIL, PEG-7 HYDROGENATED CASTOR OIL, PROPYLPARABEN, SODIUM LACTATE, SORBITAN ISOSTEARATE, UREA, WATER

Questions Or Comments? (Questions or comments?)

1-866-735-4137

Distributed By:

Galderma Laboratories, L.P.

Dallas, TX 75201

All trademarks are the property of their respective owners.

Made in Canada

cetaphil.com

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

Dimethicone 2%......Skin protectant

Principle Display Panel 16 Fl Oz Pump Label (PRINCIPLE DISPLAY PANEL - 16 FL OZ pump label)

Dermatologist Recommended

For Sensitive Skin



Cetaphil®



Cracked Skin Repair Lotion

Skin Protectant Dimethicone

Rough, Cracked Sensitive Skin

Daily use lotion is designed to hydrate

and restore rough skin and prevent

cracked skin from coming back.



Urea

5 skin sensitivity signs

16 FL OZ (473 mL)



P56383-1


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)