SPL v1
SPL
SPL Set ID cca5a149-01ed-41f8-9cb7-258b94ac94ab
Route
TOPICAL
Published
Effective Date 2012-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (99.9 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-12-20
Description

Active Ingredient Mineral Oil 99.9%

Medication Information

Warnings and Precautions

Warnings

For External Use Only.

Indications and Usage

Uses

  • Helps moisturize delicate skin and helps prevent chafing.
  • Use after shower or bath for superior moisturizing, helping skin stay soft and smooth.
  • Also used as make-up remover from delicate skin.
Dosage and Administration

Directions

Apply product liberally, as often as necessary.

Description

Active Ingredient Mineral Oil 99.9%

Section 42229-5

PRINCIPAL DISPLAY PANEL

Pan Aromas Baby Oil

NET WT. 10 FL OZ (296 mL)

Section 50565-1

Keep out of the reach of children

Children if swallowed get medical help or contact Poison Control Center right away.

Section 51727-6

Inactive Ingredient

Fragrance

Section 51945-4

Section 55105-1
Purpose

Skin Protectant

Section 55106-9

Active Ingredient

Mineral Oil 99.9%

Structured Label Content

Indications and Usage (34067-9)

Uses

  • Helps moisturize delicate skin and helps prevent chafing.
  • Use after shower or bath for superior moisturizing, helping skin stay soft and smooth.
  • Also used as make-up remover from delicate skin.
Dosage and Administration (34068-7)

Directions

Apply product liberally, as often as necessary.

Warnings and Precautions (34071-1)

Warnings

For External Use Only.

Section 42229-5 (42229-5)

PRINCIPAL DISPLAY PANEL

Pan Aromas Baby Oil

NET WT. 10 FL OZ (296 mL)

Section 50565-1 (50565-1)

Keep out of the reach of children

Children if swallowed get medical help or contact Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredient

Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)
Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Mineral Oil 99.9%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:34.238949 · Updated: 2026-03-14T22:53:21.930902