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Product NDC Code | 69919-526 | ||||||
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Drug Name | Humane acne wash 5 |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LIQUID | ||||||
RxCUI drug identifier | 308696 | ||||||
Application Number | M006 | ||||||
Labeler Name | Humane Consumer, LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzoyl Peroxide 5% Purpose Acne Treatment
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 New User: Test 1-2 small affected areas for sensitivity for 3 days. If no discomfort occurs, apply acne wash and gently massage into damp skin. Wait 1-3 minutes for wash to absorb. Rinse thoroughly.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua (Deionized Water), Carbomer, Cocamidopropyl Betaine, Gluconolactone, Sodium Benzoate, Sodium Hydroxide
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.Use for the treatment of 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.HUMANE Acne Wash 5 BENZOYL PEROXIDE WATER CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE COCAMIDOPROPYL BETAINE GLUCONOLACTONE SODIUM BENZOATE SODIUM HYDROXIDE 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.69919-526-08 Outer Label1 Inner Label1
69919-526-16 Outer Label Inner Label2
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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 are sensitive to benzoyl peroxide or have very sensitive skin. Using other topical acne drugs at the same time or right after use of this product may increase dryness, redness or irritation of the skin. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to twice daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
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? thehumanecompany.com
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 excessive irritation occurs.
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 Avoid contact with and near eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. Avoid unnecessary sun exposure and use a sunscreen. Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
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 are sensitive to benzoyl peroxide or have very sensitive skin. Using other topical acne drugs at the same time or right after use of this product may increase dryness, redness or irritation of the skin. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to twice daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. When using this product Avoid contact with and near eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. Avoid unnecessary sun exposure and use a sunscreen. Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product. Stop use and ask a doctor if excessive irritation occurs. Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breastfeeding, 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