FDA.reportPublic FDA data

Othine Skin Bleach Cream

Manufacturer
J. Strickland & Co.
Effective date
2018-01-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:04:42

Label at a glance#

ProductOthine Skin Bleach
Active ingredientHYDROQUINONE, OCTISALATE
Label structure6 sections

Indications and uses

Gradually fades areas of skin discoloration such as age spots  freckles  liver spots  dark areas that can occur while using oral contraceptives.

Dosage and administration

If skin is sensitive, test on a small area inside elbow overnight before use.  Adults and children 12 years and older, apply as a thin layer to affected area twice daily, or as directed by a doctor. If going outside, use a sunscreen or wear protective clothing Children under 12 years of age, ask a doctor before use.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone, 3%; Octisalate, 3%

Purpose

OTC - PURPOSE SECTION

Skin Lightener

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Gradually fades areas of skin discoloration such as

  • age spots 
  • freckles 
  • liver spots 
  • dark areas that can occur while using oral contraceptives.

Warnings:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on inflamed or broken skin 
  • to prevent sunburn 
  • if product is tan or brown.

When using this product,

OTC - WHEN USING SECTION

  • mild irritation may occur 
  • avoid contact with eyes. If contact occurs, rinse with water.
  • avoid unnecessary sun exposure and use a sunscreen or protective clothing

Stop use and consukt a doctor if

OTC - STOP USE SECTION

  • a gradual blue-black darkening of the skin occurs 
  • irritation becomes severe
  • no improvement is seen after 3 months 

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

consult a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

consult a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • If skin is sensitive, test on a small area inside elbow overnight before use. 
  • Adults and children 12 years and older, apply as a thin layer to affected area twice daily, or as directed by a doctor.
  • If going outside, use a sunscreen or wear protective clothing
  • Children under 12 years of age, ask a doctor before use.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

water, mineral oil, stearyl alcohol, decyl oleate, glyceryl stearate, oleth-20, laureth-23, propylene glycol, stearamidopropyl dimethylamine, citric acid, sodium metabisulfite, methylparaben, propylparaben, fragrance

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12022-016-0012022-016-00

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12022-01612022-016-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
STEARYL ALCOHOL2KR89I4H1YIACT
DECYL OLEATEZGR06DO97TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
OLETH-20YTH167I2AGIACT
LAURETH-23N72LMW566GIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM METABISULFITE4VON5FNS3CIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
HYDROQUINONEXV74C1N1AEACTIB
OCTISALATE4X49Y0596WACTIB

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
b34cbc02-95e5-3b76-e053-2a95a90a98c003e2bbac-f31a-407f-aa3e-639851c6c00a2020-11-04WarningsExact identifier
spl set id: 03e2bbac-f31a-407f-aa3e-639851c6c00a

Reported adverse events (FAERS/openFDA)#

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