CLEAR-N-SMOOTH- skin lightening cream cream

Clear-N-Smooth by

Drug Labeling and Warnings

Clear-N-Smooth by is a Otc medication manufactured, distributed, or labeled by Hawknad Manufacturing Industries, Inc., EMS Acquisition Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, water.

Active Ingredient

Hydroquinone - 2%

Principal Display Panel

INGREDIENTS AND APPEARANCE

CLEAR-N-SMOOTH 
skin lightening cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76445-0043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	8.1 g  in 100 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	0.3 g  in 100 g
STEARYL STEARATE (UNII: 5WX2EGD0DK)	1.5 g  in 100 g
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)	3.5 g  in 100 g
CETYL ALCOHOL (UNII: 936JST6JCN)	3.5 g  in 100 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	4 g  in 100 g
DIMETHICONE 350 (UNII: 2Y53S6ATLU)	1 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.25 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51)	3 g  in 100 g
LIGHT MINERAL OIL (UNII: N6K5787QVP)	4 g  in 100 g
ETHYLHEXYL PALMITATE (UNII: 2865993309)	2 g  in 100 g
PEG-100 STEARATE (UNII: YD01N1999R)	2 dL  in 100 g
ASCORBIC ACID (UNII: PQ6CK8PD0R)	0.1 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.1 g  in 100 g
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	0.3 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T)	0.1 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.1 g  in 100 g
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	0.2 g  in 100 g
WATER (UNII: 059QF0KO0R)	57.6 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	5.6 g  in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.1 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76445-0043-4	118 g in 1 JAR; Type 0: Not a Combination Product	01/15/2001

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, Inc. (618892426)

Registrant - Hawknad Manufacturing Industries, Inc. (618892426)

Establishment
Name	Address	ID/FEI	Business Operations
EMS Acquisition Group		048602791	manufacture(76445-0043)