Major 069.001/069aa

Major 069.001/069aa
SPL v18
SPL
SPL Set ID 0e7e11c5-a1f8-43c4-b8a6-211491052404
Route
TOPICAL
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (1 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-07-11

Description

White Petrolatum USP (100%)

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

White Petrolatum USP (100%)

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

For external use only

Directions

apply as needed

Dislcaimer

*This product is not manufactured or distributed by Unilever, distributor of Vaseline ® Original Healing Jelly Skin Protectant.

Questions?

1-888-593-0593

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Adverse Reaction

Dist. by MAJOR ®PHARMACEUTICALS

Indianapolis, IN 46268 (800) 616-2471

www.major-rugby.com

Re-order No. 100123

Rev. 03/25 M-97

Active Ingredient

White Petrolatum USP (100%)

Inactive Ingredient

None

When Using This Product
  • do not get into eyes
Principal Display Panel

NDC 0904-5731-82

MAJOR ®

Compare to Vaseline ®*

Petroleum Jelly

White Petrolatum USP 100%

Skin Protectant

NET WT 13 OZ (368 g)

Rev. 03/25

Keep Out of Reach of Children.

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

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

Structured Label Content

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

Skin protectant

Warnings

For external use only

Directions

apply as needed

Dislcaimer

*This product is not manufactured or distributed by Unilever, distributor of Vaseline ® Original Healing Jelly Skin Protectant.

Questions?

1-888-593-0593

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Adverse Reaction (ADVERSE REACTION)

Dist. by MAJOR ®PHARMACEUTICALS

Indianapolis, IN 46268 (800) 616-2471

www.major-rugby.com

Re-order No. 100123

Rev. 03/25 M-97

Active Ingredient (Active ingredient)

White Petrolatum USP (100%)

Inactive Ingredient (Inactive ingredient)

None

When Using This Product (When using this product)
  • do not get into eyes
Principal Display Panel (principal display panel)

NDC 0904-5731-82

MAJOR ®

Compare to Vaseline ®*

Petroleum Jelly

White Petrolatum USP 100%

Skin Protectant

NET WT 13 OZ (368 g)

Rev. 03/25

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.

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)