Label: ACTIV O2 ACNE TREATMENT CREAM- sulfur cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71577-222-50 - 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 19, 2017
If you are a consumer or patient please visit this version.
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- 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 •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
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Directions
USE ONE TO THREE TIMES DAILY
- clean the skin thoroughly before applying this product.
- cover the entire affected area with a thin layer 1 to 3 times a day.
- if bothersome dryness or peeling occurs, reduce application to 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
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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.comMade in South Africa
Distributed / Imported / Marketed by:
Miller Methods Imports
3921 Alton Road, Miami Beach FL, 33140You may report serious side effects to the above address
INSPIRED BY NATURE
PERFECTED BY SCIENCE
ADVANCED SCIENTIFIC FORMULATION
- Packaging
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INGREDIENTS AND APPEARANCE
ACTIV O2 ACNE TREATMENT CREAM
sulfur creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71577-222 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 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:71577-222-50 1 in 1 CARTON 09/27/2017 1 50 mL in 1 JAR; 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 09/27/2017 Labeler - Activ Ozone (pty) Ltd (539181712) Establishment Name Address ID/FEI Business Operations Activ Ozone (pty) Ltd 539181712 manufacture(71577-222)
