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Product NDC Code | 66184-155 | ||||
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Drug Name | Sally hansen microwavable eybrow, face and lip wax kit |
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Type | Brand | ||||
Route | TOPICAL | ||||
Dosage Form | KIT | ||||
RxCUI drug identifier | 1373322 | ||||
Application Number | part333B | ||||
Labeler Name | Coty US LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 5% Benzocaine
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 shake well use no more than 3 to 4 times daily Adults and children 2 years of age and older apply to treated area immediately after hair removal Children under 2 years of age consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua/Water/Eau, Ethylhexyl Palmitate, Paraffinum Liquidum/ Mineral Oil/Huile Minerale, Propylene Glycol, Glyceryl Stearate, Cetyl Alcohol, Palmitic Acid, Triethanolamine, Stearic Acid, Imidazolidinyl Urea, Parfum/Fragrance, Peg-100 Stearate, Methylparaben, Carbomer, Tocopheryl Acetate, Lanolin Alcohol, Linalool, Benzyl Benzoate, Aloe Barbadensis Leaf Extract, Alcohol, Myristic Acid, Limonene, Geraniol, Citronellol, Eugenol, Citral, Soluble Collagen, Propylparaben, Citric Acid, Benzoic Acid, Tocopherol, BHT.
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 temporary relief of pain and itching associated with minor skin irritations due to hair removal
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Sally Hansen Microwavable Eybrow, Face and Lip Wax Kit Benzocaine Sally Hansen Microwavable Eybrow, Face and Lip Wax Kit Benzocaine WATER ETHYLHEXYL PALMITATE MINERAL OIL PROPYLENE GLYCOL GLYCERYL MONOSTEARATE CETYL ALCOHOL PALMITIC ACID TROLAMINE STEARIC ACID IMIDUREA PEG-100 STEARATE METHYLPARABEN .ALPHA.-TOCOPHEROL ACETATE LANOLIN ALCOHOLS LINALOOL, (+/-)- BENZYL BENZOATE ALOE VERA LEAF ALCOHOL MYRISTIC ACID GERANIOL .BETA.-CITRONELLOL, (R)- EUGENOL CITRAL PROPYLPARABEN CITRIC ACID MONOHYDRATE BENZOIC ACID TOCOPHEROL BUTYLATED HYDROXYTOLUENE BENZOCAINE BENZOCAINE Sally Hansen Microwavable Eybrow, Face and Lip Wax Kit WHITE WAX CALCIUM CARBONATE MAGNESIUM CARBONATE MINERAL OIL CANOLA OIL COCONUT OIL APRICOT KERNEL OIL CHAMOMILE ALOE VERA LEAF D&C RED NO. 17
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 – Kit Label MICROWABLE Eyebrow, Face & Lip WAX KIT WAX • Results last up to 8 weeks!* • With mini tweezers & brow guides Topical analgesic with 5 % benzocaine • des resultants jusqu'à 8 semaines !* • avec mini pince à épiler et guides pour les sourcils analgésique local avec 5 % de benzocaïne *Individual results may vary *les resultants individuals prevent varier Wax / cire NET WT. 1.25 oz 35 g, Extrasoothe™ Lotion / lotion 0.5 fl oz 14.7 ml, Brow Guides / guides pour les sourcils, Temperature Indicator Applicator . applicateur avec indicateur de temperature, Mini Tweezers / mini pince à épiler, Orange Stick / bâtonnet orange, Instuctions Principal Display Panel – Kit 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
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 in large quantities, over raws surfaces, or blistered areas
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 or comments? Call us at 1-800-953-5080 9:00AM - 5:00PM EST
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 condition worsens symptoms last for more than 7 days or clear up and occur again within a few days
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 eyes
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 Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. For external use only When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens symptoms last for more than 7 days or clear up and occur again within a few days Do not use in large quantities, over raws surfaces, or blistered areas 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