COLDSORE BOMB- zinc oxide ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Zinc Oxide (2.5mgs per 1g of product by input weight)
Available from:
Envisionate PSJ LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
External analgesic For temporary relief of pain and itching associated with fever blisters and cold sores
Authorization status:
OTC monograph not final
Authorization number:
72883-019-01

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)

Purpos e

External analgesic

Us e

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

Envisionate PSJ LLC

COLDSORE BOMB

zinc oxide ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:728 8 3-0 19

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

2.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

LANO LIN (UNII: 7EV6 5EAW6 H)

CO CO A BUTTER (UNII: 512OYT1CRR)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

GRAPE SEED O IL (UNII: 9 30 MLC8 XGG)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

TEA TREE O IL (UNII: VIF56 5UC2G)

CRO TO N LECHLERI RESIN (UNII: GGG6 W25C6 3)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:728 8 3-0 19 -0 1

1 in 1 BOX

0 3/25/20 19

1

3.5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 3/25/20 19

Labeler -

Envisionate PSJ LLC (116959523)

Revised: 3/2019

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