Clear-N-Smooth: Package Insert and Label Information

CLEAR-N-SMOOTH- hydroquinone cream
Hawknad Manufacturing Industries

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Indications for Use

  • Lightens dark colorations in the skin such as freckles, age, and liver spots
  • Contains a sunscreen to help prevent darkening from re-occurring.

Purpose

Skin Lightening Cream

Dosage

Moisten a cotton ball and apply a thin layer over the entire affected area.

Keep Out of Reach of Children

Children under 12 years of age: do not use unless directed by a doctor.

Warnings

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

This product is not for use for the prevention of sunburn.

When using this product avoid contact with eyes.

Some users of this product may experience a mild skin irritation. If irritation becomes severe, stop use and consult a doctor.

Instructions for Use

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. Sun exposure should be limited by using a sunscreen agent, a protective clothing to cover bleached skin after treatment is completed in order to prevent darkening from re-occurring.

Inactive Ingredients

ascorbic acid, cetyl alcohol, citric acid, diazolidinyl urea, dimethicone, disodium EDTA, Fragrance, glyceryl stearate, isopropyl myristate, lanolin alcohol, methyl paraben, propyl paraben, mineral oil, propylene glycol, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, stearyl stearate, tocopherol acetate, glabridin, water.

Active Ingredient

Hydroquinone — 2%

Principal Display Panel

Product Label
(click image for full-size original)

CLEAR-N-SMOOTH
ultimate skin lightening cream cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76445-0415
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE 8.1 g in 100 g
SODIUM LAURYL SULFATE 0.3 g in 100 g
STEARYL STEARATE 1.5 g in 100 g
STEARYL ALCOHOL 3.5 g in 100 g
CETYL ALCOHOL 3.5 g in 100 g
ISOPROPYL MYRISTATE 4 g in 100 g
DIMETHICONE 350 1 g in 100 g
.ALPHA.-TOCOPHEROL ACETATE 0.25 g in 100 g
OCTINOXATE 3 g in 100 g
LIGHT MINERAL OIL 4 g in 100 g
ETHYLHEXYL PALMITATE 2 g in 100 g
PEG-100 STEARATE 2 dL in 100 g
ASCORBIC ACID 0.1 g in 100 g
ANHYDROUS CITRIC ACID 0.1 g in 100 g
SODIUM METABISULFITE (BISULFITE ION) 0.3 g in 100 g
METHYLPARABEN 0.1 g in 100 g
PROPYLPARABEN 0.1 g in 100 g
DIAZOLIDINYL UREA 0.2 g in 100 g
WATER 57.6 g in 100 g
PROPYLENE GLYCOL 5.6 g in 100 g
EDETATE DISODIUM 0.1 g in 100 g
GLABRIDIN 0.08 g in 100 g
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76445-0415-4 118 g in 1 JAR None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part358A 01/02/1992
Labeler — Hawknad Manufacturing Industries (618892426)
Registrant — Hawknad Manufacturing Industries (618892426)
Establishment
Name Address ID/FEI Operations
EMS Acquisition Group 048602791 manufacture (76445-0415)

Revised: 12/2019 Hawknad Manufacturing Industries

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