LYSIMAX- benzalkonium chloride, menthol, petrolatum ointment 
Alva-Amco Pharmacal Companies, Inc.

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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Lysimax

Active Ingredients

Benzalkonium chloride, 0.13%

Menthol, 1%

White petrolatum, 97%

Purpose

  • First aid antiseptic
  • Topical analgesic
  • Skin protectant

Uses

  • For temporary relief of pain and itching associated with fever blisters and cold sores.
  • First aid to protect against skin infection in minor cuts, scrapes and burns.
  • Helps prevent, temporarily protects and helps relieve chapped or cracked lips.

Warnings

For external use only.

Do not use

  • in the eyes
  • over large areas of the body
  • in case of:
  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • avoid contact with eyes.

Stop use and ask a doctor if

  • the condition gets worse
  • persists for more than 7 days or clears up and occurs 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

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Apply Lysimax to affected area not more than 3 to 4 times daily.
  • Massage gently until absorbed into the skin.
  • Intended for use by normally healthy adults only.
  • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.

Other information

You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Lysine HCl, purified water.

Questions?  1-800-792-2582

LysimaxPDP

LYSIMAX 
benzalkonium chloride, menthol, petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-638
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM970 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-638-071 in 1 CARTON09/04/201304/30/2018
1NDC:52389-638-017 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/04/201304/30/2018
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 12/2018
 
Alva-Amco Pharmacal Companies, Inc.