Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d998b9f4-5e7c-4656-91f7-c1c8041b473d
Route
TOPICAL
Published
Effective Date 2011-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydroquinone (1.14 g) Padimate O (.285 g)
Inactive Ingredients
Water Glyceryl Stearate Citrate Cetostearyl Alcohol Glycerin Isopropyl Myristate Allantoin Ascorbic Acid Sodium Metabisulfite Sodium Citrate Sodium Lauryl Sulfate Edetate Disodium Methylparaben Propylparaben Chlorocresol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-01-01
Description

Hydroquinone 2% Padimate O, 0.5%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage



Dosage and Administration



Description

Hydroquinone 2% Padimate O, 0.5%

Section 50565-1



Section 50567-7

Avoid contact with eyes.

Section 50570-1

On children under 12 years of age unless directed by a doctor

Section 51727-6



Section 51945-4

Section 55105-1

Skin Lightener

Section 55106-9

Hydroquinone 2%

Padimate O, 0.5%

Structured Label Content

Indications and Usage (34067-9)



Dosage and Administration (34068-7)



Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)



Section 50567-7 (50567-7)

Avoid contact with eyes.

Section 50570-1 (50570-1)

On children under 12 years of age unless directed by a doctor

Section 51727-6 (51727-6)



Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Lightener

Section 55106-9 (55106-9)

Hydroquinone 2%

Padimate O, 0.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:15.439173 · Updated: 2026-03-14T22:52:39.796827