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Vanibiss butt and thighs acne treatment cream - Medication Information

Product NDC Code 81890-192
Drug Name

Vanibiss butt and thighs acne treatment cream

Type Brand
Active Ingredients
Salicylic acid 20 mg/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 317152
Application Number M006
Labeler Name Vanibiss Inc
Packages
Package NDC Code Description
81890-192-00 1 jar in 1 box (81890-192-00) / 118.3 ml in 1 jar
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Salicylic Acid 2.0% 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: clean the skin thoroughly before applying this product cover the entire affected area 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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Beeswax, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oil, Centella Asiatica (Gotu Kola) Extarct, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cyclopentasiloxane, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel) Distillate, Hydroxyethyl Acrylate/Sodium (Flax) Seed Oil, Mentha Piperita (Peppermint) Oil, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extarct, Salix Alba (Willow) Bark Extarct, Sodium Hydroxide, Sorbitan Olivate, Tetrasodium EDTA, Thymus Vulgaris (Thyme) Extarct, Zemea (Corn) propanediol, Zinc Oxide.

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 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.
VANIBISS BUTT and THIGHS Acne Treatment Cream SALICYLIC ACID ALOE VERA LEAF WATER ASCORBIC ACID YELLOW WAX SHEA BUTTER GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL SAFFLOWER CENTELLA ASIATICA LEAF CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE CETEARYL OLIVATE CETYL ALCOHOL CITRIC ACID MONOHYDRATE CYCLOMETHICONE 5 GLYCERYL MONOSTEARATE GLYCYRRHIZA GLABRA HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK LINSEED OIL PEPPERMINT OIL PHENOXYETHANOL POLYSORBATE 20 ROSEMARY SALIX ALBA BARK SODIUM HYDROXIDE SORBITAN OLIVATE EDETATE SODIUM THYME CORN ZINC OXIDE SALICYLIC ACID SALICYLIC ACID

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 Labeling: 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 Other information: Protect the product in this container from excessive heat and direct sun.

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? 1-800-410-8461

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.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, 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 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 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