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| Product NDC Code | 82767-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Butt and thighs acne treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 317152 | ||||
| Application Number | M006 | ||||
| Labeler Name | Teamtrade Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.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 the skin thoroughly before applying product. Cover the entire affected area with a thin layer one to three times daily. Because excess 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Aqua, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Caprylic/Capric Triglyceride, Beeswax, Glycerin, Polyglyceryl-6 Palmitate/Succinate, Cetearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cetyl Alcohol, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Organic Butyrospermum Parkii (Shea) Butter, Dimethicone, Dimethicone Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Parfum, Sodium Hydroxide, Xanthan Gum, Disodium EDTA, Rosmarinus Officinalis (Rosemary) Extract, Tocopheryl Acetate, Mentha Piperita (Peppermint) Oil, Salix Alba Bark Extract, Camellia Sinensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hexyl Cinnamal, D-Limonene, Linalool, Benzyl Salicylate, Benzyl Alcohol, Citral.
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.BUTT AND THIGHS ACNE TREATMENT SALICYLIC ACID DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER SALICYLIC ACID SALICYLIC ACID POLYGLYCERIN-6 GREEN TEA LEAF PHENOXYETHANOL CETOSTEARYL ALCOHOL ALMOND OIL CETYL ALCOHOL SHEA BUTTER XANTHAN GUM PROPYLENE GLYCOL LAURETH-7 GLYCERIN CAPRYLYL GLYCOL EDETATE DISODIUM .ALPHA.-TOCOPHEROL ACETATE C13-14 ISOPARAFFIN HEXYLENE GLYCOL LIMONENE, (+)- ALOE VERA LEAF TEA TREE OIL MEDIUM-CHAIN TRIGLYCERIDES WHITE WAX GLYCERYL STEARATE/PEG-100 STEARATE SODIUM HYDROXIDE ROSEMARY PEPPERMINT OIL .ALPHA.-HEXYLCINNAMALDEHYDE LINALOOL, (+/-)- BENZYL SALICYLATE BENZYL ALCOHOL CITRAL WATER SALIX ALBA BARK
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.BUTT & THIGHS ACNE TREATMENT CREAM 4oz (Label - Box) SEROFLORA BUTT AND THIGHS
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.If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.See on the top of the tube for lot number and expiration date. Protect the product in this container from excessive heat and direct sun.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call (1-877-737-6267)
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 consult a doctor if Condition worsens or does not improve with regular use of this product as directed.
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.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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding Consult a health care 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.For external use only. Do not use on children under 12 years of age unless directed by a doctor.
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