Label: ACTIV O2 ACNE TREATMENT- salicylic acid lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71577-333-75 - Packager: Activ Ozone (pty) Ltd
- 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.
Drug Label Information
Updated September 18, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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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
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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
- Inactive ingredients
- Other information
- Questions?
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SPL UNCLASSIFIED SECTION
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
WITH ACTIVE OZONE TECHNOLOGY
Performs skin clearing action
Based on organic ozonised plant oils.
Apply one to three times daily.
First wash face with ACTIV O2 Acne Treatment Cleansing Bar then apply the lotion thinly onto the affected areas. Gently massage in small circles.
Avoid the eye area.
Provides effective relief from acne and blemishes and helps prevent the development of new acne blemishes, acne pimples, blackheads and whiteheads.
- Packaging
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INGREDIENTS AND APPEARANCE
ACTIV O2 ACNE TREATMENT
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71577-333 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 mL Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71577-333-75 1 in 1 CARTON 09/22/2017 1 75 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/22/2017 Labeler - Activ Ozone (pty) Ltd (539181712) Establishment Name Address ID/FEI Business Operations Activ Ozone (pty) Ltd 539181712 manufacture(71577-333)
