SPL v2
SPL
SPL Set ID c66ee098-8f62-4c4c-b1ab-5fef84f4b22a
Route
TOPICAL
Published
Effective Date 2012-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (1 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-03-10
Description

Active ingredient White Petrolatum USP (100 %)

Medication Information

Warnings and Precautions

Warning s

For External Use Only.

Indications and Usage

Use s

For the temporary protection of minor cuts, scrapes and burns.

  • Helps relieve cracked or chapped lips and skin.
  • Helps to protect from the drying effects of wind and cold weather.
  • Helps reduce the appearance of fine dry lines.
  • May be used daily all over your body, face and hands.
Dosage and Administration

Directions

Apply as needed.

Description

Active ingredient White Petrolatum USP (100 %)

Section 50565-1

Keep out of reach of children.

If swallowed get medical help or contact a poison control center immediately.

Section 50566-9

See a doctor if condition lasts for 7 days.

Section 50567-7

When using this product

Avoid contact with eyes.

Section 50570-1

Do not use on

  • serious burns
  • deep or puncture wounds
  • animal bites
Section 51727-6

Inactive ingredients

None

Section 51945-4

PRINCIPAL DISPLAY PANEL

100% PURE PETROLEUM JELLY

For all your moisturizing needs

Net Wt. 4 oz. (113g) 4 onzas

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active ingredient

White Petrolatum USP (100 %)

Structured Label Content

Indications and Usage (34067-9)

Use s

For the temporary protection of minor cuts, scrapes and burns.

  • Helps relieve cracked or chapped lips and skin.
  • Helps to protect from the drying effects of wind and cold weather.
  • Helps reduce the appearance of fine dry lines.
  • May be used daily all over your body, face and hands.
Dosage and Administration (34068-7)

Directions

Apply as needed.

Warnings and Precautions (34071-1)

Warning s

For External Use Only.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed get medical help or contact a poison control center immediately.

Section 50566-9 (50566-9)

See a doctor if condition lasts for 7 days.

Section 50567-7 (50567-7)

When using this product

Avoid contact with eyes.

Section 50570-1 (50570-1)

Do not use on

  • serious burns
  • deep or puncture wounds
  • animal bites
Section 51727-6 (51727-6)

Inactive ingredients

None

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

100% PURE PETROLEUM JELLY

For all your moisturizing needs

Net Wt. 4 oz. (113g) 4 onzas

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active ingredient

White Petrolatum USP (100 %)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:33.111851 · Updated: 2026-03-14T22:53:19.872567