NDC 71577-222 Activ O2 Acne Treatment Cream

NDC Product Code 71577-222

NDC CODE: 71577-222

Proprietary Name: Activ O2 Acne Treatment Cream What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

NDC Code Structure

  • 71577 - Activ Ozone (pty) Ltd

NDC 71577-222-50

Package Description: 1 JAR in 1 CARTON > 50 mL in 1 JAR

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Activ O2 Acne Treatment Cream with NDC 71577-222 is a product labeled by Activ Ozone (pty) Ltd. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 315220.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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 Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Activ Ozone (pty) Ltd
Labeler Code: 71577
Start Marketing Date: 09-27-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Activ O2 Acne Treatment Cream Product Label Images

Activ O2 Acne Treatment Cream Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 onlyWhen 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

Otc - 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 DAILYclean 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

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?

+1-917-676-2003Available during working hours: (9am - 5pm) Monday to Friday

Other

Manufactured by:ACTIV OZONE (Pty) Ltd.77, 10th Road, Kew, Johannesburg, South Africa, 2090.Tel: +27-11-887-1752.     www.activo2.comMade in South AfricaDistributed / Imported / Marketed by:Miller Methods Imports3921 Alton Road, Miami Beach FL, 33140You may report serious side effects to the above addressINSPIRED BY NATUREPERFECTED BY SCIENCEADVANCED SCIENTIFIC FORMULATION

* Please review the disclaimer below.