ACTIV O2 ACNE TREATMENT CREAM- sulfur cream 
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 CREAM

Drug Facts

Active ingredient

Sulfur (10%)

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.

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 •avoid unnecessary sun exposure and use a sunscreen after using this product •skin irritation may occur such as redness, burning, itching and peeling •do not use on broken skin

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

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive Ingredients

Cetearyl Alcohol, Disodium EDTA, Ethylhexyl Cocoate, Fragrance (Parfum), Jojoba (Simmondsia Chinensis) Seed Oil, Olive (Olea Europaea) Fruit Oil, Phenoxyethanol, Polysorbate 20, Potassium Cetyl Phosphate, PPG-3 Benzyl Ether Myristate, Sodium Polyacrylate, Water (Aqua)

Other information

• store below 25 °C

Questions?

+1-917-676-2003

Available during working hours: (9am - 5pm) Monday to Friday

Manufactured by:
ACTIV OZONE (Pty) Ltd.
77, 10th Road, Kew, Johannesburg, South Africa, 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

ADVANCED SCIENTIFIC FORMULATION

Packaging

image description

ACTIV O2 ACNE TREATMENT CREAM 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71577-222
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYL COCOATE (UNII: I1MPW273QS)  
JOJOBA OIL (UNII: 724GKU717M)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71577-222-501 in 1 CARTON09/27/2017
150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/27/2017
Labeler - Activ Ozone (pty) Ltd (539181712)
Establishment
NameAddressID/FEIBusiness Operations
Activ Ozone (pty) Ltd539181712manufacture(71577-222)

Revised: 9/2017
Document Id: 0fd1b938-1faf-424e-ac82-c8814ca5cdd4
Set id: 13948732-26b5-42a6-82b6-4318683d78c3
Version: 1
Effective Time: 20170919
 
Activ Ozone (pty) Ltd