drug facts

drug facts
SPL v4
SPL
SPL Set ID fe665bbc-1172-4f59-acc6-8d5c179693b6
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 hyaluronic acid ceramide 1 ceramide np ceramide ap phenoxyethanol .alpha.-tocopherol acetate tocopherol phytosphingosine cholesterol sodium lauroyl lactylate carbomer homopolymer type a (allyl pentaerythritol crosslinked) panthenol pantolactone water lauroyl proline xanthan gum ethylhexylglycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-11-14
Purpose

Skin protectant

Description

Petrolatum 46.5%

Medication Information

Warnings

For external use only

Uses

■ helps treat and prevent diaper rash

■ protects chafed skin due to diaper rash and helps seal out wetness

Purpose

Skin protectant

Directions
  • 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 exposure to wet diapers may be prolonged
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

Description

Petrolatum 46.5%

Questions?

Toll-free number 1-888-768-2915

www.cerave.com

Section 51945-4

Active Ingredients

Petrolatum 46.5%

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

Warnings

For external use only

Uses

■ helps treat and prevent diaper rash

■ protects chafed skin due to diaper rash and helps seal out wetness

Purpose

Skin protectant

Directions
  • 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 exposure to wet diapers may be prolonged
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

Questions?

Toll-free number 1-888-768-2915

www.cerave.com

Section 51945-4 (51945-4)

Active Ingredients (Active ingredients)

Petrolatum 46.5%

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)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:38.068354 · Updated: 2026-03-14T23:02:18.218337