Herpetrol Gel

Drug Labeling and Warnings

Drug Details [pdf]

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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Herpetrol Gel

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 using.
  • Use only as directed.
  • Apply 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

HerpetrolPDP

HERPETROL 
benzalkonium chloride, menthol, petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52389-179
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: 52389-179-071 in 1 CARTON06/30/200501/31/2018
1NDC: 52389-179-017 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/30/200501/31/2018
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 12/2018
Document Id: 7cee5b84-c467-6bb2-e053-2a91aa0a5676
Set id: 2504eae6-68eb-4879-a2e6-dd8a926abcce
Version: 3
Effective Time: 20181213