SPL v1
SPL
SPL Set ID da3da8dc-267d-4d14-a35d-7e0e736bd3d4
Route
TOPICAL
Published
Effective Date 2015-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydroquinone (2 g)
Inactive Ingredients
Water Propylene Glycol Cetyl Alcohol Mineral Oil Glyceryl Monostearate Cetostearyl Alcohol Ceteareth-22 Starch, Potato Dimethicone Phenoxyethanol Trimethylpentanediol/adipic Acid/glycerin Crosspolymer (25000 Mpa.s) Lanolin Sodium Metabisulfite Methylparaben Grapefruit Peel Edetate Sodium Tetrahydrate Egg Phospholipids .alpha.-tocopherol Acetate Vitamin A Palmitate Ascorbyl Palmitate Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-05-15
Description

HYDROQUINONE 2%

Purpose

SKIN LIGHTENING

Medication Information

Purpose

SKIN LIGHTENING

Description

HYDROQUINONE 2%

Uses:

FOR THE GRADUAL FADING OF DARK AREAS IN THE SKIN SUCH AS FRECKLES, AGE AND LIVER SPOTS.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES.
  • SOME USERS OF THIS PRODUCT MAY EXPERIENCE SKIN IRRITATION. IF SKIN IRRITATION BECOMES SEVERE, STOP USE AND CONSULT A DOCTOR.

DO NOT USE

  • ON CHILDREN UNDER 12 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.

Directions

APPLY A SMALL AMOUNT AS A THIN LAYER ON THE AFFECTED AREA TWICE DAILY, OR USE AS DIRECTED BY A DOCTOR. IF NO IMPROVEMENT IS SEEN AFTER 3 MONTHS OF TREATMENT, USE OF THIS PRODUCT SHOULD BE DISCONTINUED. LIGHTENING EFFECT OF THIS PRODUCT MAY NOT BE NOTICEABLE WHEN USED ON VERY DARK SKIN. CHILDREN UNDER 12 YEARS OF AGE: DO NOT USE UNLESS DIRECTED BY A DOCTOR.

Active Ingredient

HYDROQUINONE 2%

Inactive Ingredients:

WATER, PROPYLENE GLYCOL, CETYL ALCOHOL, MINERAL OIL, GLYCERYL STEARATE, CETEARYL ALCOHOL, CETEARETH-20, POTATO STARCH MODIFIED, DIMETHICONE, FRAGRANCE, PHENOXYETHANOL, TRIMETHYLPROPANEDIOL/ADIPIC ACID COPOLYMER, LANOLIN, SODIUM METABISULFITE, METHYLPARABEN, CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL, TETRASODIUM EDTA, PHOSPHOLIPIDS, TOCOPHERYL ACETATE, RETINYL ACETATE, ASCORBYL PALMITATE, CITRIC ACID.

Structured Label Content

Uses: (USES:)

FOR THE GRADUAL FADING OF DARK AREAS IN THE SKIN SUCH AS FRECKLES, AGE AND LIVER SPOTS.

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 51945-4 (51945-4)

Purpose (PURPOSE)

SKIN LIGHTENING

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES.
  • SOME USERS OF THIS PRODUCT MAY EXPERIENCE SKIN IRRITATION. IF SKIN IRRITATION BECOMES SEVERE, STOP USE AND CONSULT A DOCTOR.

DO NOT USE

  • ON CHILDREN UNDER 12 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.

Directions (DIRECTIONS)

APPLY A SMALL AMOUNT AS A THIN LAYER ON THE AFFECTED AREA TWICE DAILY, OR USE AS DIRECTED BY A DOCTOR. IF NO IMPROVEMENT IS SEEN AFTER 3 MONTHS OF TREATMENT, USE OF THIS PRODUCT SHOULD BE DISCONTINUED. LIGHTENING EFFECT OF THIS PRODUCT MAY NOT BE NOTICEABLE WHEN USED ON VERY DARK SKIN. CHILDREN UNDER 12 YEARS OF AGE: DO NOT USE UNLESS DIRECTED BY A DOCTOR.

Active Ingredient (ACTIVE INGREDIENT)

HYDROQUINONE 2%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER, PROPYLENE GLYCOL, CETYL ALCOHOL, MINERAL OIL, GLYCERYL STEARATE, CETEARYL ALCOHOL, CETEARETH-20, POTATO STARCH MODIFIED, DIMETHICONE, FRAGRANCE, PHENOXYETHANOL, TRIMETHYLPROPANEDIOL/ADIPIC ACID COPOLYMER, LANOLIN, SODIUM METABISULFITE, METHYLPARABEN, CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL, TETRASODIUM EDTA, PHOSPHOLIPIDS, TOCOPHERYL ACETATE, RETINYL ACETATE, ASCORBYL PALMITATE, CITRIC ACID.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:56.809008 · Updated: 2026-03-14T22:54:00.925910