Bactine ® Max Pain Relieving Cleansing Spray

Drug Labeling and Warnings

Drug Details [pdf]

BACTINE MAX- benzalkonium chloride and lidocaine hydrochloride spray 
Denison Pharmaceuticals, LLC

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:

  • cuts
  • scrapes
  • minor burns
  • sunburn
  • minor skin irritations

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

  • adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first)
  • children under 2 years, ask a doctor

Other information

avoid excessive heat

Inactive ingredients

edetate disodium, fragrances, nonoxynol 9, 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.

backlabel

BACTINE MAX 
benzalkonium chloride and lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0295-9009
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: 0295-9009-17118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/08/2019
2NDC: 0295-9009-55148 mL in 1 BOTTLE; Type 0: Not a Combination Product03/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/08/2019
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaeuticals, LLC001207208manufacture(0295-9009)

Revised: 3/2019
Document Id: 839c78aa-3b02-fb8d-e053-2a91aa0ab199
Set id: 839c78aa-3b01-fb8d-e053-2a91aa0ab199
Version: 1
Effective Time: 20190308