Petroleum Jelly

Petroleum Jelly
SPL v6
SPL
SPL Set ID 4e02af41-db86-46d8-a97d-332d84eced6f
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
White Petrolatum (1 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

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 chafed, chapped or cracked skin
  • helps protect against the drying effects of wind and cold weather
Warnings

For external use only

Directions

apply as needed

Distributror

Distributor:

ALDERMED INC.

7901 4TH ST N STE 300 ST PETERSBURG, FL 33702

www.aldermed.us MADE IN INDIA MH/DRUGS/25-KD/739

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Active Ingredient

White petrolatum USP 100%

Other Information
  • store at 15°- 30°C (59° to 86° F)
Inactive Ingredients

none

Questions Or Comments?

Call 1-833-605-84-74 9am-5 pm EST M-F

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.

In swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Structured Label Content

Uses

temporarily protects minor

  • cuts
  • scrapes
  • burns
  • temporarily protects and chafed, chapped or cracked skin
  • helps protect against the drying effects of wind and cold weather
Purpose

Skin protectant

Warnings

For external use only

Directions

apply as needed

Distributror

Distributor:

ALDERMED INC.

7901 4TH ST N STE 300 ST PETERSBURG, FL 33702

www.aldermed.us MADE IN INDIA MH/DRUGS/25-KD/739

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Active Ingredient (Active ingredient)

White petrolatum USP 100%

Other Information (Other information)
  • store at 15°- 30°C (59° to 86° F)
Inactive Ingredients (Inactive ingredients)

none

Questions Or Comments? (Questions or comments?)

Call 1-833-605-84-74 9am-5 pm EST M-F

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.)

In swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Advanced Ingredient Data


Raw Label Data

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