CLEAR-N-SMOOTH- supermax lotion 
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 Supermax Skin Lightening Lotion

Indications for Use

Purpose

Skin Lightening Cream

Dosage

Scoop a thin layer and apply 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 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

Principal Display Panel

Label

CLEAR-N-SMOOTH 
supermax lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76445-1555
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) 5.5 g  in 100 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 0.3 g  in 100 g
STEARYL STEARATE (UNII: 5WX2EGD0DK) 1 g  in 100 g
STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 3.5 g  in 100 g
CETYL ALCOHOL (UNII: 936JST6JCN) 2 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) 2.65 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) 0.5 g  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) 64.65 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:76445-1555-6176 g in 1 BOTTLE, DISPENSING; 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 Corp048602791manufacture(76445-1555)

Revised: 10/2019
Document Id: 95832dbc-3c26-2a3f-e053-2995a90a8b7f
Set id: 8e503af8-1013-8c8a-e053-2995a90aeb92
Version: 5
Effective Time: 20191022
 
Hawknad Manufacturing Industries