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| Product NDC Code | 73690-023 | ||||
|---|---|---|---|---|---|
| Drug Name | Back-up plan acne-control body mist |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 1048903 | ||||
| Application Number | M006 | ||||
| Labeler Name | Offspring Beauty Co. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid 2 %
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 spray to cover the entire affected area of the back with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 sensitivity test for a new user: apply product sparingly to one or two small affected areas during 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 Water/Aqua/Eau, Dipropylene Glycol, Polysorbate 20, Hamamelis Virginiana (Witch Hazel) Water, Glycereth-7 Trimethyl Ether, Glycereth-26, Methyl Gluceth-20, Sodium Hydroxide, Glycerin, Phenoxyethanol, Panthenol, Sodium Benzoate, Allantoin, Butylene Glycol, Disodium EDTA, Ethylhexylglycerin, Dipotassium Glycyrrhizate, Benzoic Acid, Sodium Hyaluronate, Citric Acid, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Oenothera Biennis (Evening Primrose) Oil, Glycyrrhiza Glabra (Licorice) Root Extract.
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 management 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.BACK-UP PLAN ACNE-CONTROL BODY MIST Salicylic Acid Salicylic Acid Salicylic Acid WATER DIPROPYLENE GLYCOL POLYSORBATE 20 HAMAMELIS VIRGINIANA TOP WATER GLYCERETH-7 TRIMETHYL ETHER GLYCERETH-26 METHYL GLUCETH-20 SODIUM HYDROXIDE GLYCERIN PHENOXYETHANOL PANTHENOL SODIUM BENZOATE ALLANTOIN BUTYLENE GLYCOL EDETATE DISODIUM ANHYDROUS ETHYLHEXYLGLYCERIN GLYCYRRHIZINATE DIPOTASSIUM HYALURONATE SODIUM MELALEUCA ALTERNIFOLIA LEAF EVENING PRIMROSE OIL CITRIC ACID MONOHYDRATE GLYCYRRHIZA GLABRA BENZOIC ACID Clear/Translucent
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.PRINCIPAL DISPLAY PANEL - 100 ml Bottle Label 2% SALICYLIC ACID ACNE TREATMENT VERSED BACK-UP PLAN ACNE-CONTROL BODY MIST tea tree oil + witch hazel 3 fl. oz. | 100 ml PRINCIPAL DISPLAY PANEL - 100 ml Bottle Label
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
Dist. by Offspring Beauty Co. West Hollywood, CA 90069
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.
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 spraying into eyes. contents under pressure. do not puncture or incinerate. do not store at temperature above 120°F/50°C.
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. 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 spraying into eyes. contents under pressure. do not puncture or incinerate. do not store at temperature above 120°F/50°C. Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.
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