COLDSORE BOMB by Envisionate PSJ LLC COLDSORE BOMB

COLDSORE BOMB by

Drug Labeling and Warnings

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

Drug Details [pdf]

COLDSORE BOMB- zinc oxide 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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COLDSORE BOMB

Drug Facts

Active ingredients

Zinc Oxide (2.5mgs per 1g of product by input weight)

Purpose

External analgesic

Use

For temporary relief of pain and itching associated with fever blisters and cold sores

Warnings

For external use only

Stop use and ask a doctor if Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

When using this product Avoid contact with the eyes

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Directions

• Adults and children 2 years of age and older: Apply to the affected area not more than 3-4 times daily
• Children under 2 years of age: Consult a doctor

Other Information

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

Inactive Ingredients

Lanolin, Cocoa Butter, Coconut Oil, Grapeseed Oil, Peppermint Oil, Tea Tree Oil, Croton Lechleri Sap (Dragons Blood)

Questions or Comments?

(801) 623-1595

M-F 9am-5pm or visit our website at ColdsoreBomb.com

"Explosive Cold Sore Relief"

100% ALL NATURAL

Distributed By: Envisionate PSJ Lehi UT 84043

NDC: 72883-019-01

Packaging

COLDSORE BOMB 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72883-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.5 mg  in 1 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)
TEA TREE OIL (UNII: VIF565UC2G)
CROTON LECHLERI RESIN (UNII: GGG6W25C63)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72883-019-01	1 in 1 BOX	03/25/2019	05/01/2019
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 not final	part348	03/25/2019	05/01/2019

Labeler - Envisionate PSJ LLC (116959523)

Establishment
Name	Address	ID/FEI	Business Operations
Paket Corporation		007774730	manufacture(72883-019)

Revised: 12/2019

Document Id: 9502ff50-4bdd-4912-b376-17263537d23b

34390-5

Set id: 4bf22314-d9c8-49ce-951f-28cfd189f3f2

Version: 2

Effective Time: 20191210

 

Envisionate PSJ LLC