BACTINE MAX DRY- lidocaine hydrochloride spray 
WellSpring Pharmaceutical Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bactine® Max Pain Relieving Cleansing Spray


Drug Facts

Active Ingredients

Lidocaine 4%

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

Child-resistant packaging. Replace cap after each use

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 Dry Spray 4oz

BACTINE MAX DRY 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-815
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOBUTANE (UNII: BXR49TP611)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65197-815-04175 mL in 1 CAN; Type 0: Not a Combination Product01/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/31/2023
Labeler - WellSpring Pharmaceutical Corporation (110999054)

Revised: 12/2022
Document Id: a3f5d68c-431b-47c1-90ca-952862ed4641
Set id: 466404cd-c46a-4944-b1ac-3b3b17f436a1
Version: 2
Effective Time: 20221227
 
WellSpring Pharmaceutical Corporation