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Will relieve roll-on - Medication Information

Product NDC Code 82630-002
Drug Name

Will relieve roll-on

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine hydrochloride 3.2 g/88ml
Route TOPICAL
Dosage Form GEL
Application Number part348
Labeler Name Will Perform, PBC
Packages
Package NDC Code Description
82630-002-01 1 bottle, with applicator in 1 carton (82630-002-01) / 88 ml in 1 bottle, with applicator
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Lidocaine HCl 4%

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 adults and children over 12 years: apply a thin layer over the affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period children 12 years or younger: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., aminomethyl propanol, angelica polymorpha sinensis root extract, arnica montana flower extract, bisabolol, caprylic/capric triglyceride, capryloyl glycerin/sebacic acid copolymer, diheptyl succinate, fragrance, glycerin, water

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 temporary relief of pain

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.
Will Relieve Roll-On Lidocaine Hydrochloride Lidocaine Hydrochloride LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS Water CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) Alcohol Glycerin Medium-Chain Triglycerides DIHEPTYL SUCCINATE CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) LEVOMENOL ANGELICA SINENSIS ROOT AMINOMETHYLPROPANOL Arnica Montana Flower

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 - 88 mL Bottle Carton WILL™ PERFORM BY SERENA WILLIAMS FAST ACTING PAIN RELIEF ROLL-ON lidocaine 3 FL OZ (88 mL) PRINCIPAL DISPLAY PANEL - 88 mL Bottle Carton

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 Distributed by Will Perform, PBC, 4040 Civic Center Drive, #200, San Rafael, CA 94903

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 on large areas of the body or on a cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor

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 and pets if swallowed, get medical help or contact a Poison Control Center right away

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 conditions worsen redness is present irritation develops symptoms persist 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 use only as directed. Read and follow all directions and warnings on this carton do not allow contact with eyes and mucous membranes do not bandage or apply local heat (such as heating pads) or medicated patch to the area of use do not use at the same time as other topical analgesics

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breastfeeding, ask a healthcare 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 Flammable keep away from excessive heat or open flame Do not use on large areas of the body or on a cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor When using this product use only as directed. Read and follow all directions and warnings on this carton do not allow contact with eyes and mucous membranes do not bandage or apply local heat (such as heating pads) or medicated patch to the area of use do not use at the same time as other topical analgesics Stop use and ask a doctor if conditions worsen redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breastfeeding, ask a healthcare professional before use Keep out of reach of children and pets 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