CLEAR-N-SMOOTH- supermax lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)
Available from:
Hawknad Manufacturing Industries
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- Lightens dark colorations in the skin such as freckles, age, and liver spots - Contains a sunscreen to help prevent darkening from re-occurring. Skin Lightening Cream 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.
Authorization status:
OTC monograph not final
Authorization number:
76445-1555-6

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

Lightens dark colorations in the skin such as freckles, age, and liver spots

Contains a sunscreen to help prevent darkening from re-occurring.

Purpos e

Skin Lightening Cream

Dos age

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

CLEAR-N-SMOOTH

supermax lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:76 445-1555

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO Q UINO NE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)

HYDROQUINONE

2 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

5.5 g in 10 0 g

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

0 .3 g in 10 0 g

STEARYL STEARATE (UNII: 5WX2EGD0 DK)

1 g in 10 0 g

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

3.5 g in 10 0 g

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

2 g in 10 0 g

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

4 g in 10 0 g

DIMETHICO NE 3 50 (UNII: 2Y53S6 ATLU)

1 g in 10 0 g

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

0 .25 g in 10 0 g

O CTINO XATE (UNII: 4Y5P7MUD51)

2.6 5 g in 10 0 g

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

4 g in 10 0 g

ETHYLHEXYL PALMITATE (UNII: 28 6 59 9 330 9 )

2 g in 10 0 g

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

0 .5 g in 10 0 g

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

0 .1 g in 10 0 g

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

0 .1 g in 10 0 g

SO DIUM METABISULFITE (UNII: 4VON5FNS3C)

0 .3 g in 10 0 g

METHYLPARABEN (UNII: A2I8 C7HI9 T)

0 .1 g in 10 0 g

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

0 .1 g in 10 0 g

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

0 .2 g in 10 0 g

WATER (UNII: 0 59 QF0 KO0 R)

6 4.6 5 g in 10 0 g

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

5.6 g in 10 0 g

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

0 .1 g in 10 0 g

GLABRIDIN (UNII: HOC556 7T41)

0 .0 5 g in 10 0 g

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:76 445-1555-

176 g in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/15/20 0 1

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt358 A

0 1/0 2/19 9 2

Labeler -

Hawknad Manufacturing Industries (618892426)

Registrant -

Hawknad Manufacturing Industries (618892426)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Hawknad Manufacturing Industries

EMS Acquisitio n Co rp

0 48 6 0 279 1

ma nufa c ture (76 445-1555)

Revised: 10/2019

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