Label: CLEAR-N-SMOOTH ULTRAMAX lotion
- NDC Code(s): 76445-0497-6
- Packager: Hawknad Manufacturing Industries, Inc.
- Category: COSMETIC
- DEA Schedule: None
- Marketing Status: OTC monograph not final
Updated February 17, 2015
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- FRONT OF LABEL
- ACTIVE INGREDIENTS
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.
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 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