TUVIVEX- menthol, unspecified form gel

Tuvivex by

Drug Labeling and Warnings

Tuvivex by is a Otc medication manufactured, distributed, or labeled by Tuvive Therapeutics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Menthol 4%

Purpose

Topical Analgesic

Uses

Aid for temporary local relief of minor pain in muscles or joints.

Warnings

• For external use only.
• Avoid contact with eyes.
• Do not apply to wounds or damaged skin.
• If symptoms persist for more than seven days, discontinue use and consult a physician.

IF PREGNANT OR BREASTFEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help right away.

Directions

Adults and children two years of age or older:

• Apply to affected area not more than three to four times daily.
• Children under two years of age, consult a physician.

Additional Information

Store in a cool, dry ptace at 20 to 25 C (68 to77 F) with lid closed tightly.

Inactive Ingredients

Aqua, Alcohol Denat, Steareth-21, Glycerin, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Hemp-Derived Cannabidiol (CBD), Arnica Montana Flower Extract, Steareth-2, Cetyl Alcohol, Xanthan Gum, Boswellia Serrata Extract.

QUESTIONS

To report a serious adverse event or to obtain product information, contact Company number at 1-844-720-7251

PRINCIPAL DISPLAY PANEL - 90 mL Bottle Label

Tuvīve
Therapeutics

73501-500-90

Tuvīvex™
Menthol 4% Roll on Gel
with CBD

Roll On
Pain Gel

CBD
500MG
Per Bottle

3 fl. oz (90 mL)

INGREDIENTS AND APPEARANCE

TUVIVEX 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73501-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
Steareth-21 (UNII: 53J3F32P58)
Glycerin (UNII: PDC6A3C0OX)
Caprylyl Glycol (UNII: 00YIU5438U)
Phenoxyethanol (UNII: HIE492ZZ3T)
Hexylene Glycol (UNII: KEH0A3F75J)
CANNABIDIOL (UNII: 19GBJ60SN5)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
Steareth-2 (UNII: V56DFE46J5)
Cetyl Alcohol (UNII: 936JST6JCN)
Xanthan Gum (UNII: TTV12P4NEE)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73501-500-90	90 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	02/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	02/10/2020

Labeler - Tuvive Therapeutics (117298967)