Dual Action Skin Lightener

Manufacturer
Neoteric Cosmetics, Inc.
Effective date
2020-09-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:16:19

Label at a glance#

ProductDual Action Skin Lightener
Active ingredientHYDROQUINONE
Label structure8 sections

Indications and uses

• Lightens dark spots in the skin, such as freckles, age spots, and liver spots.

Dosage and administration

• Adults: apply a thin layer on the affected areas twice daily, or 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 this product unless directed by a doctor. Sun exposure should be limited by using a sunscreen a...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dual Action Skin Lightener

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

Purpose

OTC - PURPOSE SECTION

Skin Lightener

Uses

INDICATIONS & USAGE SECTION

• Lightens dark spots in the skin, such as freckles, age spots, and liver spots.

Warnings

WARNINGS SECTION

• Avoid contact with eyelids and eyes

• Some users of this product may experience a mild 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.

OTC - DO NOT USE SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults: apply a thin layer on the affected areas twice daily, or 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 this product unless directed by a doctor. Sun exposure should be limited by using a sunscreen agent, sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Sunburn Alert

• This product contains an Alpha Hydroxy Acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycolic Acid, Propylene Glycol, Isopropyl Palmitate, Mineral Oil, Glyceryl Stearate, Cetyl Alcohol, Ozokerite, Sodium Hydroxide, Steareth-20, Laureth-23, Tocopherol (Vitamin E), Dimethicone, Xanthan Gum, Sodium PVM/MA Decadiene Crosspolymer, Sorbic Acid, Sodium Metabisulfite, Imidazolidinyl Urea, Tetrasodium EDTA, Fragrance, BHT

MANUFACTURED FOR NEOTERIC COSMETICS, INC., Greenwood Village, CO 80111

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alpha
skin care
Dual Action
Skin Lightener
Net Wt. 0.85 oz. (24g)

Alpha skin care Dual Action Skin Lightener Net Wt. 0.85 oz. (24g)Alpha skin care Dual Action Skin Lightener Net Wt. 0.85 oz. (24g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62673-162-212022-09-15C16284748780-1d6a99b39-e0d7-a426-e053-dadaa90af4c2Dual Action Skin Lightener
62673-162-212022-01-28C16284748780-1d6a99b39-e0d7-a426-e053-dadaa90af4c2Dual Action Skin Lightener

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62673-16262673-162-21

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
07c23911-d5f9-4ad3-9434-6671c59807f30aa9ee02-abc7-450b-b377-f264aebb3cf82022-09-19WarningsExact identifier
spl set id: 0aa9ee02-abc7-450b-b377-f264aebb3cf8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.