drug facts

drug facts
SPL v2
SPL
SPL Set ID b8832ee7-3e13-456b-b301-dad7473a032b
Route
topical
Published
Effective Date 2019-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (30 g)
Inactive Ingredients
water glycerin glyceryl monostearate peg-100 stearate stearic acid polyoxyl 20 cetostearyl ether trolamine lanolin alcohols carbomer copolymer type a (allyl pentaerythritol crosslinked) phenoxyethanol triethylene glycol .alpha.-tocopherol acetate edetate disodium

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2019-02-04
Purpose

Skin protectant

Description

White Petrolatum USP (30 %)

Medication Information

Warnings

For external use only.

Do not use on deep puncture wounds, animal bites and serious burns.

Uses
  • temporarily protects minor:
    • cuts
    • scrapes
    • burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Purpose

Skin protectant

Directions

Apply as needed.

Inactive Ingredients

water (aqua), glycerine, glyceryl monostearate, PEG 100 stearate, stearic acid, ceteareth 20, triethanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, tocopheryl acetate, disodium EDTA

Description

White Petrolatum USP (30 %)

Section 50567-7

When using this product, do not get into eyes.

Active Ingredient:

White Petrolatum USP (30 %)

Stop Use and Ask Doctor If
  • condition worsens,
  • symptoms last more than 7 days
  • 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 right away.

Principal Display Panel Petroleum Jelly Tube Label

ASSURED™

Vitamin E Enriched

Creamy

PETROLEUM

JELLY

Skin Softener

For Dry Skin

Absorbs Quickly

Compare to active ingredient of

Vaseline ® Deep Moisture™

Net Wt 3 oz (85g)

NDC # 33992-0499-1

Structured Label Content

Warnings

For external use only.

Do not use on deep puncture wounds, animal bites and serious burns.

Uses
  • temporarily protects minor:
    • cuts
    • scrapes
    • burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Purpose

Skin protectant

Directions

Apply as needed.

Inactive Ingredients (Inactive ingredients)

water (aqua), glycerine, glyceryl monostearate, PEG 100 stearate, stearic acid, ceteareth 20, triethanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, tocopheryl acetate, disodium EDTA

Section 50567-7 (50567-7)

When using this product, do not get into eyes.

Active Ingredient: (Active ingredient:)

White Petrolatum USP (30 %)

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • condition worsens,
  • symptoms last more than 7 days
  • 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 right away.

Principal Display Panel Petroleum Jelly Tube Label (Principal Display Panel - Petroleum Jelly Tube Label)

ASSURED™

Vitamin E Enriched

Creamy

PETROLEUM

JELLY

Skin Softener

For Dry Skin

Absorbs Quickly

Compare to active ingredient of

Vaseline ® Deep Moisture™

Net Wt 3 oz (85g)

NDC # 33992-0499-1

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:45.560757 · Updated: 2026-03-14T22:55:26.303656