ACTIV O2 ACNE TREATMENT CLEANSING BAR- salicylic acid soap 
Activ Ozone (pty) 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.

----------

ACTIV O2 ACNE TREATMENT CLEANSING BAR

Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Uses

• for the management or treatment of acne. Clears up acne blemishes, acne pimples, blackheads, whiteheads, and allows skin to heal. • helps prevent the development of new acne pimples, blackheads and whiteheads.

Warnings

For external use only
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 contact with the eyes, lips and mouth. • skin irritation may occur such as redness, burning, itching and peeling.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

USE ONE TO THREE TIMES DAILY

• wet your face or affected body parts with luke warm water, lather soap in hands. Massage lather onto skin with a gentle, circular motion for 20 to 30 seconds. Rinse thoroughly and gently pat dry. Follow with ACTIV O2 Acne Treatment Lotion or Cream. • avoid contact with eyes, lips and mouth

Inactive ingredients

Butylated Hydroxytoluene, Disodium Edetate, Glycerin, Jojoba (Simmondsia Chinensis) Seed Oil, Olive (Olea Europaea) Fruit Oil, Sodium Lauryl Sulphate, Sodium Palmitate, Sodium Palm Kernelate

Other information

• store below 25 ​°C

Questions?

+1-917-676-2004 Available during working hours: (9am – 5pm) Monday to Friday

Manufactured by: ACTIV OZONE (Pty) Ltd.
77, 10th Road, Kew, Johannesburg, South Arica, 2090. Tel: +27-11-887-1752. www.activo2.com

Made in South Africa

Distributed / Imported / Marketed by:
Miller Methods Imports,3921 Alton Road, Miami Beach FL, 33140
You may report serious side effects to the above address
INSPIRED BY NATURE
PERFECTED BY SCIENCE
FRAGRANCE FREE

Packaging

image description

ACTIV O2 ACNE TREATMENT CLEANSING BAR 
salicylic acid soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71577-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
JOJOBA OIL (UNII: 724GKU717M)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PALMITATE (UNII: JQ43KP6296)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71577-111-12125 g in 1 CARTON; Type 0: Not a Combination Product09/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/28/2017
Labeler - Activ Ozone (pty) Ltd (539181712)
Establishment
NameAddressID/FEIBusiness Operations
Activ Ozone (pty) Ltd539181712manufacture(71577-111)

Revised: 9/2017
Document Id: b084dd3f-d59b-4e03-8ab5-4edc8b7d3e80
Set id: c7f618bd-1fcd-48b7-9e19-b2f9ce95bb7f
Version: 1
Effective Time: 20170918
 
Activ Ozone (pty) Ltd