GOLD COSMETICS BLEACH CREAM SILVER- hydroquinone cream cream

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

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Active ingredient:
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)
Available from:
Peer Pharm Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Face cream for gradual fading of dark spots Face cream for gradual fading of dark spots Apply a very thin layer once a day, only at night, all over the face
Authorization status:
OTC monograph not final
Authorization number:
69435-1903-1

GOLD COSMETICS BLEACH CREAM SILVER- hydroquinone cream cream

Peer Pharm Ltd

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.

----------

Bleach Cream Silver

Hydroquinone 5%

Face cream for gradual fading of dark spots

Face cream for gradual fading of dark spots

Apply a very thin layer once a day, only at night, all over the face

Apply a very thin layer once a day, only at night, all over the face

Warnings:

Sun exposure should be limit by using a sunscreen agent, a sun blocking agent, or protective clothing to

cover bleached skin

when using and after using this product in order to prevent darkening from reoccurring.

Proper use of skin bleaching creams is extremely important, and directions should be followed

carefully at all times.

Large skin areas, such as the entire face, should not be bleached at once due to the possibility of skin

discoloration.

Product should be used on the darkened area of skin only.

For external use only.

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children

GOLD COSMETICS BLEACH CREAM SILVER

hydroquinone cream cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 435-19 0 3

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

5 mg in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

JO JO BA O IL (UNII: 724GKU717M)

DECYL O LEATE (UNII: ZGR0 6 DO9 7T)

SO DIUM METABISULFITE (UNII: 4VON5FNS3C)

XANTHAN GUM (UNII: TTV12P4NEE)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

Peer Pharm Ltd

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

WATER (UNII: 0 59 QF0 KO0 R)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

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

CETEARETH-3 0 (UNII: 1R9 DCZ5FOX)

STEARETH-2 1 (UNII: 53J3F32P58 )

STEARETH-2 (UNII: V56 DFE46 J5)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

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

ALLANTO IN (UNII: 344S277G0 Z)

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

KO JIC ACID (UNII: 6 K23F1TT52)

O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 435-19 0 3-1

30 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 5/20 19

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 9 /0 5/20 19

Labeler -

Peer Pharm Ltd (514678390)

Registrant -

Peer Pharm Ltd (514678390)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Peer Pharm Ltd

5146 78 39 0

manufacture(6 9 435-19 0 3) , label(6 9 435-19 0 3)

Revised: 9/2019

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