SPL v1
SPL
SPL Set ID 2b061f8a-74b0-9958-e063-6394a90aba45
Route
CUTANEOUS
Published
Effective Date 2025-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (3 mg) Glycerin (5 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-06
Description

Keep out of children

Medication Information

Warnings and Precautions

Keep out of children

Indications and Usage

For daily skin care

Dosage and Administration

Apply to affected area twice per dayon cleansed skin.Use continuously for 2-3 weeks for best results.

Description

Keep out of children

Section 50565-1

Keep out of children

Section 51727-6

Aqua

Section 51945-4

Section 55105-1

Keep Hip firming and moisturizing

Structured Label Content

Indications and Usage (34067-9)

For daily skin care

Dosage and Administration (34068-7)

Apply to affected area twice per dayon cleansed skin.Use continuously for 2-3 weeks for best results.

Warnings and Precautions (34071-1)

Keep out of children

Section 50565-1 (50565-1)

Keep out of children

Section 51727-6 (51727-6)

Aqua

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Keep Hip firming and moisturizing

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:13.589670 · Updated: 2026-03-14T23:06:42.095401