COLDSORE BOMB- menthol ointment

COLDSORE BOMB by

Drug Labeling and Warnings

COLDSORE BOMB by is a Otc medication manufactured, distributed, or labeled by Envisionate PSJ LLC, Paket Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Menthol 1%

Purpose

External analgesic

WARNINGS

Directions

• Adults and children 2 years of age and older: Apply to the affected area not more than 5 times daily.

INDICATIONS & USAGE

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

INGREDIENTS AND APPEARANCE

COLDSORE BOMB 
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72883-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72883-020-01	1 in 1 BOX	12/09/2019
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/09/2019

Labeler - Envisionate PSJ LLC (116959523)

Registrant - Envisionate PSJ LLC (116959523)

Establishment
Name	Address	ID/FEI	Business Operations
Paket Corporation		007774730	manufacture(72883-020)