Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (46.5 g)
Inactive Ingredients
Mineral Oil Paraffin Ceresin Dimethicone Ceramide 1 Ceramide 3 Ceramide 6 Ii Carbomer Homopolymer, Unspecified Type Water Sodium Lauroyl Lactylate Lauroyl Proline Cholesterol Phenoxyethanol .alpha.-tocopherol Acetate Tocopherol Hyaluronic Acid Panthenol Pantolactone Phytosphingosine Xanthan Gum Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-20

Description

Petrolatum 46.5%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Petrolatum 46.5%

Uses

• temporarily protects and helps relieve chafed, chapped or cracked skin

  • temporarily protects minor: ● cuts ● scrapes ● burns
  • helps protect from the drying effects of wind and cold weather

Section 51945-4

Warnings

For external use only

Directions

apply as needed

Questions?

Toll-Free Number 1-888-768-2915

www.cerave.com

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient

Petrolatum 46.5%

Inactive Ingredients

mineral oil, paraffin, ozokerite, dimethicone, ceramide NP, ceramide AP, ceramide EOP, carbomer, water, sodium lauroyl lactylate, proline, cholesterol, phenoxyethanol, tocopheryl acetate, tocopherol, hydrolyzed hyaluronic acid, panthenol, pantolactone, phytosphingosine, xanthan gum, ethylhexylglycerin

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
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

• temporarily protects and helps relieve chafed, chapped or cracked skin

  • temporarily protects minor: ● cuts ● scrapes ● burns
  • helps protect from the drying effects of wind and cold weather

Section 51945-4 (51945-4)

Purpose

Skin protectant

Warnings

For external use only

Directions

apply as needed

Questions?

Toll-Free Number 1-888-768-2915

www.cerave.com

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient (Active ingredient)

Petrolatum 46.5%

Inactive Ingredients (Inactive ingredients)

mineral oil, paraffin, ozokerite, dimethicone, ceramide NP, ceramide AP, ceramide EOP, carbomer, water, sodium lauroyl lactylate, proline, cholesterol, phenoxyethanol, tocopheryl acetate, tocopherol, hydrolyzed hyaluronic acid, panthenol, pantolactone, phytosphingosine, xanthan gum, ethylhexylglycerin

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 more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)