SPL v4
SPL
SPL Set ID 5828df37-2a42-4129-8e4e-d5ac9c4c9615
Route
TOPICAL
Published
Effective Date 2013-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (0.1 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-07-28
Description

Active Ingredient White Petroleum (99.9%)

Medication Information

Warnings and Precautions

Warning:

For External Use Only.

Indications and Usage

Uses:

  • Temporarily protects minor cuts, scrapes or burns.

  • Temporarily protects and helps relieve chapped or cracked skin and lips.

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

Dosage and Administration

Directions:

Apply as often as necessary.

Description

Active Ingredient White Petroleum (99.9%)

Section 50565-1

Keep out of reach of children

  • if swallowed get medical help or contact Poison Control Center right away.
  • if redness or swelling developes, consult a physician promptly.
Section 50566-9

Stop use and ask doctor

  • if condition does not improve or lasts more than 7 days.
Section 50570-1

Do not use on:

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

Inactive Ingredients:

None.

Section 51945-4

PRINCIPAL DISPLAY PANEL

HEALTH SMART LAVENDER BABY PETROLEUM JELLY

NET WT. 8OZ. (226G)

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredient

White Petroleum (99.9%)

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Temporarily protects minor cuts, scrapes or burns.

  • Temporarily protects and helps relieve chapped or cracked skin and lips.

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

Dosage and Administration (34068-7)

Directions:

Apply as often as necessary.

Warnings and Precautions (34071-1)

Warning:

For External Use Only.

Section 50565-1 (50565-1)

Keep out of reach of children

  • if swallowed get medical help or contact Poison Control Center right away.
  • if redness or swelling developes, consult a physician promptly.
Section 50566-9 (50566-9)

Stop use and ask doctor

  • if condition does not improve or lasts more than 7 days.
Section 50570-1 (50570-1)

Do not use on:

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

Inactive Ingredients:

None.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

HEALTH SMART LAVENDER BABY PETROLEUM JELLY

NET WT. 8OZ. (226G)

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

White Petroleum (99.9%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:57.743976 · Updated: 2026-03-14T23:06:08.994677