COLDSORE BOMB- menthol ointment 
Envisionate PSJ 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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Drug Facts

Active ingredients

Menthol 1%

Purpose

External analgesic

Directions

Other Information

Store at room temperature 68 to 77°F (20 to 25ºC).

Inactive Ingredients

Cocoa Butter, Coconut Oil, Croton Lechleri, Grapeseed Oil, Lanolin, Peppermint Oil, Tea Tree Oil

Packaging

menthol

COLDSORE BOMB 
menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72883-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
COCOA BUTTER (UNII: 512OYT1CRR)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72883-020-011 in 1 BOX12/09/2019
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/09/2019
Labeler - Envisionate PSJ LLC (116959523)
Registrant - Envisionate PSJ LLC (116959523)
Establishment
NameAddressID/FEIBusiness Operations
Paket Corporation007774730manufacture(72883-020)

Revised: 10/2020
Document Id: 0d47f277-97c2-4dcd-9324-5cdb6f31412c
Set id: f5d5f4c6-fb92-402e-bc22-c4b80aeb51ea
Version: 2
Effective Time: 20201002
 
Envisionate PSJ LLC