LONAZEM- menthol,petrolatum ointment 
PEER PHARM LTD.

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Active Ingredients

Menthol 0.1%
Petrolatum 80%

Purpose

Menthol…….Antipruritic
Petrolatum…..Protectant

Uses

Warnings

if condition worsens or does not improve within 7 days, consult a doctor


do not exceed the recommended daily dosage unless directed by a doctor


in case of bleeding, consult a doctor promptly

If Pregnant or Breastfeeding, ask a healthcare provider before using.

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

Directions

Inactive Ingredients

butyrospermum parkii (shea) butter, cetearyl alcohol, juniper berry volatile oil, origanum vulgare leaf extract, rosmarinus officinalis leaf extract, thymus vulgaris leaf extract, zea mays (corn) oil

Questions or comments?

Contact us at lonazem.com or at Dorrington LLC, 7 Skyline Dr., Suite 350, Hawthorne, NY 10532

Product label

image descriptionimage description

LONAZEM 
menthol,petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM80 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
JUNIPER BERRY OIL (UNII: SZH16H44UY)  
OREGANO (UNII: 0E5AT8T16U)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
ROSEMARY (UNII: IJ67X351P9)  
CORN OIL (UNII: 8470G57WFM)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69435-1200-110 in 1 CARTON03/01/2024
13 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01503/01/2024
Labeler - PEER PHARM LTD. (514678390)
Establishment
NameAddressID/FEIBusiness Operations
PEER PHARM LTD.514678390manufacture(69435-1200)

Revised: 2/2024
Document Id: 11458d8b-3690-9cb0-e063-6294a90ac544
Set id: 91f7a741-4178-4639-9cd5-746a4b9a21bf
Version: 1
Effective Time: 20240213
 
PEER PHARM LTD.