CLEAR-N-SMOOTH- plus skin lightening cream 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.

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Listing for Clear-N-Smooth PLUS Skin Lightening Cream

Indications for Use

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

CLEAR-N-SMOOTH 
plus skin lightening cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76445-0399
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
GLABRIDIN (UNII: HOC5567T41) 0.05 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76445-0399-4118 g in 1 JAR; Type 0: Not a Combination Product01/15/2001
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A01/02/1992
Labeler - Hawknad Manufacturing Industries (618892426)
Registrant - Hawknad Manufacturing Industries (618892426)
Establishment
NameAddressID/FEIBusiness Operations
EMS Acquisition Group048602791manufacture(76445-0399)

Revised: 12/2019
Document Id: 9a00f76b-8061-d13a-e053-2a95a90ac2b9
Set id: 783cd3af-939c-0f74-e053-2991aa0a2c57
Version: 3
Effective Time: 20191218
 
Hawknad Manufacturing Industries