BACTINE MAX- benzalkonium chloride and lidocaine hydrochloride liquid 
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 ingredientsPurpose
 Benzalkonium Cl 0.13% w/w First aid antiseptic
 Lidocaine HCl 4% w/w Pain relieving spray

Uses

first aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor:

Warnings

For external use only

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not use in or near the eyes
  • do not apply over large areas of the body or in large quantities
  • do not apply over raw surfaces or blistered areas

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

avoid excessive heat

Inactive ingredients

edetate disodium, fragrances, propylene glycol, purified water

Questions?

1-844-241-5454  Mon-Fri (8-5 EST) or www.bactine.com


Money Back Guarantee

Manufactured for: WellSpring, Sarasota, FL 34243

©2018

*germs commonly associated with skin infections.

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

First Aid Pain Reliever & Antiseptic

Kills 99% of Germs*

Max Strength Germ Killing

4% Lidocaine HCL

Max Strength Pain Reliever

No Sting

 5 FL OZ (148 mL)

Front Bottle Label

DRUG FACTS LABEL

Bottle Label (Back)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

First Aid Pain Reliever & Antiseptic

Kills 99% of Germs*

Max Strength Germ Killing

4% Lidocaine HCL

Max Strength Pain Reliever

No Sting

 4 FL OZ (118 mL)

First Aid Pain Reliever & Antiseptic Kills 99% of Germs* Max Strength Germ Killing 4% Lidocaine HCL Max Strength Pain Reliever No Sting 4 FL OZ (118 mL)First Aid Pain Reliever & Antiseptic Kills 99% of Germs* Max Strength Germ Killing 4% Lidocaine HCL Max Strength Pain Reliever No Sting 4 FL OZ (118 mL)

Rear Label

BACTINE MAX 
benzalkonium chloride and lidocaine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-811
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65197-811-15148 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2018
2NDC:65197-811-14118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/17/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/22/2018
Labeler - WellSpring Pharmaceutical Corporation (110999054)

Revised: 2/2021
Document Id: 9cf6ce6f-7cdb-4dbc-9994-6c314c5f7575
Set id: 28e8a311-20a4-45a1-8d5d-ca42b101c275
Version: 8
Effective Time: 20210224
 
WellSpring Pharmaceutical Corporation