Activ O2 Acne Treatment Cleansing Bar
FDA Label NDC 71577-111

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Activ Ozone (pty) Ltd for the product Activ O2 Acne Treatment Cleansing Bar (NDC 71577-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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 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

Other

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

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