ACTIV O2 ACNE TREATMENT CLEANSING BAR- salicylic acid soap

ACTIV O2 ACNE TREATMENT CLEANSING BAR by

Drug Labeling and Warnings

ACTIV O2 ACNE TREATMENT CLEANSING BAR by is a Otc medication manufactured, distributed, or labeled by Activ Ozone (pty) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ACTIV O2 ACNE TREATMENT CLEANSING BAR 
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71577-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71577-111-12	125 g in 1 CARTON; Type 0: Not a Combination Product	09/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/28/2017

Labeler - Activ Ozone (pty) Ltd (539181712)

Establishment
Name	Address	ID/FEI	Business Operations
Activ Ozone (pty) Ltd		539181712	manufacture(71577-111)