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Bactine max dry - Medication Information

Product NDC Code 65197-815
Drug Name

Bactine max dry

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine hydrochloride 5 g/100ml
Route TOPICAL
Dosage Form SPRAY
Application Number part348
Labeler Name WellSpring Pharmaceutical Corporation
Packages
Package NDC Code Description
65197-815-04 175 ml in 1 can (65197-815-04)
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Lidocaine 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: ■ spray affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24 hour period ■ product will dry quickly on its own, and does not need to be rubbed in ■ children 12 years or younger: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients alcohol denat. (28 %) anthemis nobilis flower oil aqua arnica montana flower extract calendula officinalis flower extract Caprylic/Capric Triglyceride glycerin isobutane propylene glycol

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 temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Purpose

Information about the drug product’s indications for use.
Purpose Pain Relieving Spray

Spl product data elements

Usually a list of ingredients in a drug product.
Bactine Max Dry lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS CHAMAEMELUM NOBILE FLOWER OIL ARNICA MONTANA FLOWER CALENDULA OFFICINALIS FLOWER WATER MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN ISOBUTANE PROPYLENE GLYCOL ALCOHOL

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 NEW NDC 65197-815-04 Bactine MAX LIDOCAINE Dry Spray Anesthetic NUMBS AWAY PAIN AND ITCH MAX RELIEF FOR Minor Cuts & Scrapes, Burns, Bug bites & Sunburn QUICK-DRY 4oz (175mL) Bactine Dry Spray 4oz Artwork

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: WellSpring Pharmaceutical Corporation Sarasota, FL 34243 ©2022 Wellspring Pharmaceutical Corporation MONEYBACK GUARANTEE Bactine max is FSA/HSA eligible DOT 2Q M5706 Extremely Flammable

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Do not Use ■ in large quantities, particularly over raw surfaces or blister areas ■ on puncture wounds ■ in or near the eyes ■ longer than 1 week unless directed by 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. 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? 1-844-241-5454 or www.bactine.com

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 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 label. ■ do not allow contact with the eyes and mucous membranes ■ avoid spraying on face ■ avoid inhalation of spray ■ do not bandage or apply local heat (such as heating pads) or a medicated patch to 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 breast-feeding ask a health professional before use.

Safe handling warning

Safe Handling Warning
Child-resistant packaging. Replace cap after each 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 Do not Use ■ in large quantities, particularly over raw surfaces or blister areas ■ on puncture wounds ■ in or near the eyes ■ longer than 1 week unless directed by a doctor When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ do not allow contact with the eyes and mucous membranes ■ avoid spraying on face ■ avoid inhalation of spray ■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use ■ do not use at the same time as other topical analgesics Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days, or clear up and occur again within a few days Extremely Flammable ■ do not use near heat or flame or while smoking ■ avoid long term storage above 104°F (40°C) ■ do not puncture or incinerate. Contents under pressure. ■ do not store at temperatures above 120°F (49°C) If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Extremely Flammable ■ do not use near heat or flame or while smoking ■ avoid long term storage above 104°F (40°C) ■ do not puncture or incinerate. Contents under pressure. ■ do not store at temperatures above 120°F (49°C)

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