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| Product NDC Code | 66184-161 | ||||
|---|---|---|---|---|---|
| Drug Name | Sally hansen ouch-relief stripless hard wax kit |
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| Type | Brand | ||||
| Route | TOPICAL | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1043353 | ||||
| Application Number | part348 | ||||
| Labeler Name | Coty US LLC | ||||
| 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.Active ingredient 6% 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 Rub well (see enclosed instructions) Use wipes no more than 3 to 4 times daily. Discard wipe after use. Adults and children 13 years of age and older apply to the area to be treated 10 minutes before hair removal Children under 13 years of age consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ALCOHOL DENAT., AQUA/WATER/EAU, PROPYLENE GLYCOL, METHYLPARABEN.
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 Ouch-Relief Stripless Hard Wax Kit benzocaine Ouch-Relief Numbing Wipe Benzocaine WATER PROPYLENE GLYCOL METHYLPARABEN BENZOCAINE BENZOCAINE Azulene Oil Finishing Wipe MINERAL OIL ISOPROPYL MYRISTATE WHEAT GERM OIL PHENYLETHYL ALCOHOL CAPRYLYL GLYCOL BUTYLATED HYDROXYTOLUENE GUAIAZULENE ASCORBYL PALMITATE Wax GLYCERYL ROSINATE PARAFFIN YELLOW WAX POLYOXYL 40 HYDROGENATED CASTOR OIL ALOE VERA LEAF MICA OAT KERNEL OIL COCONUT OIL SUNFLOWER OIL .ALPHA.-TOCOPHEROL ACETATE LINALOOL, (+/-)- .BETA.-CITRONELLOL, (R)- GERANIOL .ALPHA.-HEXYLCINNAMALDEHYDE BENZYL BENZOATE ISOMETHYL-.ALPHA.-IONONE POTASSIUM SORBATE SODIUM BENZOATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) TITANIUM DIOXIDE
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 - Sally Hansen Ouch-Relief Stripless Hard Wax Kit Label OUCH-RELIEF™ STRIPLESS HARD WAX KIT PAIN- RELIEF TECHNOLOGY™ Sally Hansen ® FOR FACE & BODY Pre-Treatment Helps Reduce Pain While Waxing Results Last Up to 8 Weeks!* Body Contouring Formula Eliminates Coarse Hair *Individual hair re-growth results may vary Wax NET WT. 4.0 oz 113 g, 3 Ouch-Relief™ Numbing Wipes, 6 Spatulas, 4 Azulene Oil Finish Wipes, Instructions Dermatologist & Salon Tested Principal Display Panel - Sally Hansen Ouch-Relief Stripless Hard Wax 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.(Ouch-Relief™ Numbing Wipe)
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 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information As with all products containing benzocaine, localized allergic reactions may occur after prolonged or repeated use.
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. Not intended for use by children under 13 years of age 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 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