TETRAVIV ADVANCED COLD SORE CARE- 2% tetracaine gel

tetraVIV Advanced Cold Sore Care by

Drug Labeling and Warnings

tetraVIV Advanced Cold Sore Care by is a Otc medication manufactured, distributed, or labeled by CredoSano, Inc., Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only

When using this product do not get into the eyes or mucus membranes

Do not apply over large surfaces of the body or use:

   on deep puncture wounds

   serious burns

   or animal bites

Warnings

Stop use and ask doctor if:

   condition worsens or

   symptoms last more than 7 days

Active Ingredients

Tetracaine 2%   Analgesic/Anesthetic and Antipuritic

Mineral oil 78.4%   Skin Protectant

Uses

Topically-applied medication for the temporary relief of pain and itching assocaitd wtih fever blisters and cold sores.

Relieves dryness and softens cold sores and fever blisters

Softens crusts (scabs) associated with cold sores and fever blisters

Uses

Topically-applied medication for the temporary relief of pain and itching assocaitd wtih fever blisters and cold sores.

Relieves dryness and softens cold sores and fever blisters

Softens crusts (scabs) associated with cold sores and fever blisters

Directions

Apply as needed and use only as directed

Wash hands before and after application

Clean the affected area and rubn in gently to disperse

Treated area may be covered with a sterile bandage

Use three times per day until healed

Do not share this product with anyone

Children under 3: ask a doctor

If swallowed, get medical help or contact a poison Control Center right away.

Keep out of reach of children

Keep out of the reach of children.

Inactive Ingredients

peppermint oil, polyethylene, propylene glycol, sodium carboxymethylcellulose

Questions

Manufactured for: Credo Sano

174 Nassau Street, Suite 336, Princeton, NJ 08542

tetraviv.com

888-803-3819

Other Information

Store product at room temperature 20C - 30C (68F-86F)

Keep product in dark, dry place, if possible.

Labelling

INGREDIENTS AND APPEARANCE

TETRAVIV ADVANCED COLD SORE CARE 
2% tetracaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73170-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE	20 g  in 1000 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	784 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEPPERMINT OIL (UNII: AV092KU4JH)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Product Characteristics
Color	yellow (translucent yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73170-001-22	2.2 g in 1 TUBE; Type 0: Not a Combination Product	10/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/30/2019

Labeler - CredoSano, Inc. (117064815)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(73170-001)