Active Ingredients
Lidocaine 4%
Bactine Max Dry Spray
FDA Label NDC 65197-815
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wellspring Pharmaceutical Corporation for the product Bactine Max Dry (NDC 65197-815). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, extremely flammable, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain Relieving Spray
Uses
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.
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.
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 Ingredients
alcohol denat. (28 %)
anthemis nobilis flower oil
aqua
arnica montana flower extract
calendula officinalis flower extract
Caprylic/Capric Triglyceride
glycerin
isobutane
propylene glycol
Questions?
1-844-241-5454 or www.bactine.com
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
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)
Artwork (Bactine Max Dry Spray 4oz 1)
* Please review the disclaimer below.
