teatrical®

teatrical®
SPL v1
SPL
SPL Set ID c20869a0-1b14-4df5-aeab-ce9c85513141
Route
topical
Published
Effective Date 2020-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydroquinone (20 mg)
Inactive Ingredients
mineral oil isopropyl myristate propylene glycol cetyl alcohol polysorbate 60 peg-100 stearate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph not final active Since 2020-04-22

Purpose

Skin Lightener

Description

Drug Facts


Medication Information

Warnings

For external use only

Purpose

Skin Lightener

Directions
  • Adults: 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.
  • Exposure to the sun should be limited by using a sunscreen agent, sun blocking agent or protective clothing to cover bleached skin when using and after treatment is completed in order to prevent darkening from reoccurring.
Other Information
  • Keep tightly closed.
  • Store at room temperature.
Inactive Ingredients

water, mineral oil, glyceryl stearate, cetyl alcohol, isopropyl myristate, PEG-100 stearate, propylene glycol, cetearyl alcohol, polysorbate 60, sodium metabisulfite, stearic acid, tocopheryl acetate, beta-carotene, diazolidinyl urea, iodopropynyl butylcarbamate, fragance

Description

Drug Facts

Use

Lightens dark (brownish) spots, blotches, freckles and discolorations of the skin.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and consult a doctor if skin irritation becomes severe.

Section 50570-1

Do not use on children under 12 years of age unless directed by a doctor.

Section 53414-9

If pregnant or breast-feeding, ask a doctor before use.

Active Ingredient

Hydroquinone 2%

Questions Or Comments?

Call toll free 1-877-994-3666

When Using This Product
  • you may experience mild skin irritation
  • avoid contact with eyes.
Principal Display Panel 48 G Tube Carton

teatrical®

PRO-ACLARANT

SKIN LIGHTENING

NIGHT

CREAM

HYDROQUINONE 2%

Lightens dark spots

NET WT 1.7 OZ (48 g)


Structured Label Content

Warnings

For external use only

Purpose

Skin Lightener

Directions
  • Adults: 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.
  • Exposure to the sun should be limited by using a sunscreen agent, sun blocking agent or protective clothing to cover bleached skin when using and after treatment is completed in order to prevent darkening from reoccurring.
Other Information (Other information)
  • Keep tightly closed.
  • Store at room temperature.
Inactive Ingredients (Inactive ingredients)

water, mineral oil, glyceryl stearate, cetyl alcohol, isopropyl myristate, PEG-100 stearate, propylene glycol, cetearyl alcohol, polysorbate 60, sodium metabisulfite, stearic acid, tocopheryl acetate, beta-carotene, diazolidinyl urea, iodopropynyl butylcarbamate, fragance

Use

Lightens dark (brownish) spots, blotches, freckles and discolorations of the skin.

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

Stop use and consult a doctor if skin irritation becomes severe.

Section 50570-1 (50570-1)

Do not use on children under 12 years of age unless directed by a doctor.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a doctor before use.

Active Ingredient (Active ingredient)

Hydroquinone 2%

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-994-3666

When Using This Product (When using this product)
  • you may experience mild skin irritation
  • avoid contact with eyes.
Principal Display Panel 48 G Tube Carton (PRINCIPAL DISPLAY PANEL - 48 g Tube Carton)

teatrical®

PRO-ACLARANT

SKIN LIGHTENING

NIGHT

CREAM

HYDROQUINONE 2%

Lightens dark spots

NET WT 1.7 OZ (48 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)