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Controlling cream - Medication Information

Product NDC Code 35192-017
Drug Name

Controlling cream

Type Brand
Active Ingredients
Benzoyl peroxide .8 mg/29.6mg
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1593884
Application Number M006
Labeler Name CA-BOTANA INTERNATIONAL
Packages
Package NDC Code Description
35192-017-05 29.6 mg in 1 tube (35192-017-05)
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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.
cleanse the skin thoroughly with soft foam deep cleanse before applying. cover the entire affected aread with a thin layer 1 to 2 times daily. because too much drying of the skin may occure, start with 1 application daily, then gradually increase to 2 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. Allow benzoyl peroxide to dry the follow directions on sunscreen label.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Alpha Oligo Peptide-6 TM Calendula officinalis (Marigold) Extract Cetearyl Alcohol Cetearyl Isononanoate Cynamomum Zeylanicum Ethylhexylglycerin Glycerine Glycine Hydrogen Peroxide Mineral oil Oenothera biennis (Evening Primrose) extract Panicum Miliaceum (Millet)extract Petrolatum Phenoxyethanol Phosphatidycholine Polysorbate 60 Potassium Sorbate Rosa canina (Roseship) extract Rosmarinus officinalis (Rosemary) extract Sorbitan Stearate Tetra Sodium Water (Aqua)
Alpha Oligo Peptide-6 TM
Calendula officinalis (Marigold) Extract
Cetearyl Alcohol
Cetearyl Isononanoate
Cynamomum Zeylanicum
Ethylhexylglycerin
Glycerine
Glycine
Hydrogen Peroxide
Mineral oil
Oenothera biennis (Evening Primrose) extract
Panicum Miliaceum (Millet)extract
Petrolatum
Phenoxyethanol
Phosphatidycholine
Polysorbate 60
Potassium Sorbate
Rosa canina (Roseship) extract
Rosmarinus officinalis (Rosemary) extract
Sorbitan Stearate
Tetra Sodium
Water (Aqua)

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.
when using this product apply to affected areas only. avoid unnecessary sun exposure and use a sunscreen. do not use in or near eyes. using other topical acne drugs at the same time or right

Purpose

Information about the drug product’s indications for use.
Enter section text here

Spl product data elements

Usually a list of ingredients in a drug product.
Controlling Cream BENZOYL PEROXIDE CINNAMON BENZOYL PEROXIDE BENZOYL PEROXIDE CINNAMON LEAF OIL ETHYLHEXYLGLYCERIN GLYCERIN GLYCINE HYDROGEN PEROXIDE LIGHT MINERAL OIL OENOTHERA BIENNIS MILLET PETROLATUM PHENOXYETHANOL HYDROGENATED SOYBEAN LECITHIN POLYSORBATE 60 POTASSIUM SORBATE ROSA CANINA LEAF ROSEMARY SORBITAN MONOSTEARATE EDETATE SODIUM WATER CETOSTEARYL ALCOHOL CETEARYL ISONONANOATE

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.
image1 image2 Package label display panel

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 Posion Control Center immediately.

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 on wounds or damaged skin When using this product: use only as directed. Avoid contact with eyes. Do no bandage tightly Stop use and ask a doctor if: redness is present. Irritation develops. Condition worsens or symptoms persist more than 7 days. Symptoms clear up and occur again within a few days. Store at room temperature. Lot number and expiration date see crimp or see box.

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