Label: ACTIV O2 ACNE TREATMENT CLEANSING BAR- salicylic acid soap
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated September 18, 2017
If you are a consumer or patient please visit this version.
- Drug Facts
- Active ingredient
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
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
- Other information
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
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)