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Oxy on-the-go acne stick - Medication Information

Product NDC Code 10742-8304
Drug Name

Oxy on-the-go acne stick

Type Brand
Active Ingredients
Benzoyl peroxide 50 mg/g
Route TOPICAL
Dosage Form STICK
RxCUI drug identifier 1860177
Application Number part333D
Labeler Name The Mentholatum Company
Packages
Package NDC Code Description
10742-8304-1 1 cylinder in 1 package (10742-8304-1) / 2 g in 1 cylinder
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Benzoyl peroxide 5%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions clean skin thoroughly before applying this product cover entire affected area with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor. Sensitivity Test: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients dimethicone, methyl methacrylate/glycol dimethacrylate crosspolymer, microcrystalline wax, synthetic wax

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses treats and helps prevent acne

Purpose

Information about the drug product’s indications for use.
Purpose Acne treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Oxy On-The-Go Acne Stick benzoyl peroxide DIMETHICONE METHYL METHACRYLATE MICROCRYSTALLINE WAX SYNTHETIC WAX (1200 MW) BENZOYL PEROXIDE BENZOYL PEROXIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package/Label Principal Display Panel Oxy On-The-Go Acne Stick Principal Display Panel Drug Facts

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do Not Use if you have very sensitive skin are sensitive to benzoyl peroxide

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions 1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if irritation becomes severe

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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 unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using this product less frequently or in a lower concentration.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding Ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Storage and Handling avoid storing at temperatures above 100°F (38°C). THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS KEEP TIGHTLY CLOSED

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only Do Not Use if you have very sensitive skin are sensitive to benzoyl peroxide 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 unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using this product less frequently or in a lower concentration. Stop use and ask a doctor if irritation becomes severe If pregnant or breast-feeding Ask a health professional before use.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API