CLEAR-N-SMOOTH ULTRAMAX lotion

Clear-N-Smooth UltraMax by

Drug Labeling and Warnings

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

Drug Details [pdf]

FRONT OF LABEL

Clear-N-Smooth UltraMax

Skin Lightening Lotion

with Vitamin E and Sunscreen

ACTIVE INGREDIENTS

Hydroquinone -2.0 %, Purpose - Skin Bleaching Agent

Octinoxate - 2.5%, Purpose - Sunscreen

USES

• Lightens dark discolorations in the skin such as freckles, age and liver spots
• Contains a sunscreen to help prevent darkening from reoccurring

WARNINGS AND PRECAUTIONS

For external use only

Do not use

• On children under 12 years of age unless directed by a doctor
• This product is not for use in 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

• Adults: 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 the product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
• Children under 12 years of age: do not use unless directed by a doctor
• Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin after treatment is completed in order to prevent darkening from reoccurring.

INACTIVE INGREDIENT

ascorbic acid, cetyl alcohol, citirc acid, chamomile, diazolidinyl urea, dimethicone, disodium EDTA, fragrance, glyceryl stearate, green tea extract, hydroxyethyl cellulose, isopropyl myristate, lanolin alcohol, licorice extract, methylparaben, propylparaben, mineral oil, peg-100 stearate, propylene glycol, sodium metabisulfite, stearyl alcohol, stearyl stearate, tocopherol acetate, water. 

INGREDIENTS AND APPEARANCE

CLEAR-N-SMOOTH ULTRAMAX 
clear-n-smooth ultramax lotion

Product Information
Product Type	COSMETIC	Item Code (Source)	76445-0497
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)	.05 g  in 1 g
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	.02 g  in 1 g
PEG-100 STEARATE (UNII: YD01N1999R)	.01 g  in 1 g
STEARYL STEARATE (UNII: 5WX2EGD0DK)	.02 g  in 1 g
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)	.02 g  in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN)	.02 g  in 1 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	.04 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51)	.03 g  in 1 g
MINERAL OIL (UNII: T5L8T28FGP)	.035 g  in 1 g
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)	.005 g  in 1 g
DIMETHICONE 350 (UNII: 2Y53S6ATLU)	.01 g  in 1 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	.0025 g  in 1 g
ETHYLHEXYL PALMITATE (UNII: 2865993309)	.02 g  in 1 g
WATER (UNII: 059QF0KO0R)	.6045 g  in 1 g
EDETATE SODIUM (UNII: MP1J8420LU)	.001 g  in 1 g
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)	.005 g  in 1 g
CHAMOMILE (UNII: FGL3685T2X)	.004 g  in 1 g
SINECATECHINS (UNII: T432289GYZ)	.0025 g  in 1 g
GLABRIDIN (UNII: HOC5567T41)	.008 g  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	.056 g  in 1 g
ASCORBIC ACID (UNII: PQ6CK8PD0R)	.001 g  in 1 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	.001 g  in 1 g
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	.004 g  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T)	.001 g  in 1 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	.001 g  in 1 g
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	.002 g  in 1 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	76445-0497-6	175 g in 1 BOTTLE, PLASTIC

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)

Establishment
Name	Address	ID/FEI	Business Operations
Hawknad Manufacturing Industries, Inc.		618892426	manufacture