TOUCH ACNE TREATMENT BENZOYL PEROXIDE- benzoyl peroxide gel

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

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Active ingredient:
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)
Available from:
Touch Skin Care, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne Treatment Gel - For the treatment of acne
Authorization status:
OTC monograph final
Authorization number:
73246-001-01

TOUCH ACNE TREATMENT BENZOYL PEROXIDE- benzoyl peroxide gel

Touch Skin Care, LLC

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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Touch™ Acne Treatment Gel

Benzoyl Peroxide 2.5%

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpos e

Acne Treatment Gel

Us es

For the treatment of acne

Warnings

For external use only

Do not use if you

Have very sensitive skin

Are sensitive to benzoyl peroxide

When using this product

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the

same time. If irritation occurs, only use one topical acne medication at a time.

Avoid unnecessary sun exposure and use a sunscreen

Avoid contact with the eyes, lips, and mouth

Avoid contact with hair and dyed fabrics, which may be bleached by this product

Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.

Irritation may be erduced by using the product less frequently or in a lower concentartion.

If going outside, apply sunscreen after using this product.

If sensitivity develops or irritation becomes severe, stop use and ask a doctor

Keep out of reach of children

If swallowed get medical help or call a poison control center immediately

Keep away from excessive heat or heat sources

Directions

Clean the skin thoroughly before applying this product

Cover the entire affected area with a thin layer one to three times daily

Because excessive drying of the skin may occur, start with one application daily, then gradually

increase to two or three times daily if needed or as directed by a doctor

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other sun protection measures include limiting sun exposure and wearing protective clothing.

Other Ingredients

Carbomer, Edetate Disodium, Glycerine, Propylene Glycol, Saccharide Isomerate, Sodium Hydroxide,

Water.

Other Information

Store at 15 - 25°C (59 - 77°F) Protect from heat. Keep container tightly closed.

Distributed by Touch Skin Care, LLC

New York, NY 10003

PRINCIPAL DISPLAY PANEL - 227 g Tube Label

touch™

Acne Treatment Gel

benzoyl peroxide 2.5%

Net wt. 8 oz. (227 g)

TOUCH ACNE TREATMENT BENZOYL PEROXIDE

benzoyl peroxide gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73246 -0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Benzo yl Pero xide (UNII: W9 WZN9 A0 GM) (Benzo yl Pero xide - UNII:W9 WZN9 A0 GM)

Benzo yl Pero xide

25 mg in 1 g

Inactive Ingredients

Touch Skin Care, LLC

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Glycerin (UNII: PDC6 A3C0 OX)

Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)

Edeta te Diso dium (UNII: 7FLD9 1C8 6 K)

So dium Hydro xide (UNII: 55X0 4QC32I)

Sa ccha ride Iso mera te (UNII: W8 K377W9 8 I)

Ca rbo mer Ho mo po lymer Type C ( Allyl Penta erythrito l Cro sslinked) (UNII: 4Q9 3RCW27E)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:73246 -0 0 1-0 1

227 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 7/26 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt333D

0 7/26 /20 19

Labeler -

T ouch Skin Care, LLC (108706390)

Revised: 7/2019

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