SPL v2
SPL
SPL Set ID 82bd5d2b-a0e4-11d2-e053-2a91aa0a9f96
Route
TOPICAL
Published
Effective Date 2019-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (0.99 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-02-25
Description

Active ingredient White petrolatum USP (99.9 %)

Medication Information

Warnings and Precautions

Warning s

For external use only

Avoid contact with eyes

Indications and Usage

Uses

  • helps to soothe dry, chapped, cracked or irritated skin and lip due to cold and wind
  • for the temporary protection of minor cuts, scrapes, burns and sunburn
Dosage and Administration

Directions

  • apply liberally, as often as necessary
Description

Active ingredient White petrolatum USP (99.9 %)

Section 42229-5

PRINCIPAL DISPLAY PANEL

BABY SOFT SCENT PETROLEUM JELLY

Skin Protectant

NET WT. 6 OZ (170 g)

Section 50565-1

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if condition worsens or does not improve after 7 days.

Section 51727-6

Inactive ingredients

Fragrance

Section 51945-4

Section 55105-1

Purpose

Skin protectant

Section 55106-9

Active ingredient

White petrolatum USP (99.9 %)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps to soothe dry, chapped, cracked or irritated skin and lip due to cold and wind
  • for the temporary protection of minor cuts, scrapes, burns and sunburn
Dosage and Administration (34068-7)

Directions

  • apply liberally, as often as necessary
Warnings and Precautions (34071-1)

Warning s

For external use only

Avoid contact with eyes

Section 42229-5 (42229-5)

PRINCIPAL DISPLAY PANEL

BABY SOFT SCENT PETROLEUM JELLY

Skin Protectant

NET WT. 6 OZ (170 g)

Section 50565-1 (50565-1)

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or does not improve after 7 days.

Section 51727-6 (51727-6)

Inactive ingredients

Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Skin protectant

Section 55106-9 (55106-9)

Active ingredient

White petrolatum USP (99.9 %)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:46.202189 · Updated: 2026-03-14T22:55:26.303656