Skin Protectant With 33% Petrolatum

Skin Protectant With 33% Petrolatum
SPL v4
SPL
SPL Set ID 87413149-d39f-4f8a-b1c9-6de5eb37ff7e
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (33 g)
Inactive Ingredients
Propylparaben Sodium Chloride Water Paraffin Peg-30 Dipolyhydroxystearate Lanolin Alcohols Dmdm Hydantoin Mineral Oil Methylparaben Propylene Glycol

Identifiers & Packaging

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

Description

Petrolatum 33%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Petrolatum 33%

Label

Use(s)

• Temporarily protects and helps relieve dry, chapped, or cracked skin

• Helps protect skin from the drying effects of wind and cold weather

Warnings

For External Use Only

Do not get into eyes

Directions

Apply as needed 

Do Not Use

• On deep puncture wounds • Animal bites • Serious burns.

Questions?

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

Active Ingredient

Petrolatum 33%

Other Information

■ to open: unscrew cap, pull tab to remove foil seal

■ store at 15° to 30°C (59° to 86°F)

■ see tube crimp for lot number and expiration date

Inactive Ingredients

DMDM Hydantoin, Lanolin Alcohol, Methyl Paraben, Mineral Oil, Paraffin, PEG 30 Dipolyhydroxystearate, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride

Stop Use and Ask A Doctor If
  • Conditions 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 (1-800-222-1222) right away.


Structured Label Content

Label

Use(s)

• Temporarily protects and helps relieve dry, chapped, or cracked skin

• Helps protect skin from the drying effects of wind and cold weather

Purpose

Skin Protectant

Warnings

For External Use Only

Do not get into eyes

Directions

Apply as needed 

Do Not Use (Do not use)

• On deep puncture wounds • Animal bites • Serious burns.

Questions?

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

Active Ingredient (Active ingredient)

Petrolatum 33%

Other Information (Other information)

■ to open: unscrew cap, pull tab to remove foil seal

■ store at 15° to 30°C (59° to 86°F)

■ see tube crimp for lot number and expiration date

Inactive Ingredients

DMDM Hydantoin, Lanolin Alcohol, Methyl Paraben, Mineral Oil, Paraffin, PEG 30 Dipolyhydroxystearate, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Conditions 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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)