Label: CLEAR-N-SMOOTH- supermax lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76445-1555-6 - Packager: Hawknad Manufacturing Industries
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 22, 2019
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- Official Label (Printer Friendly)
- Indications for Use
- Purpose
- Dosage
- Keep Out of Reach of Children
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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.
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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
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INGREDIENTS AND APPEARANCE
CLEAR-N-SMOOTH
supermax lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76445-1555 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) 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76445-1555-6 176 g in 1 BOTTLE, DISPENSING; 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 (618892426) Registrant - Hawknad Manufacturing Industries (618892426) Establishment Name Address ID/FEI Business Operations EMS Acquisition Corp 048602791 manufacture(76445-1555)
