Joint and Muscle Cream by HTO Nevada Inc. DRUG FACTS

Drug Details [pdf]

JOINT AND MUSCLE CREAM- menthol cream
HTO Nevada Inc.

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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DRUG FACTS

Active Ingredients:	Purpose
Menthol USP 1.8%	Topical Analgesic

USES: Temporarily relieves minor pain

WARNINGS: For external use only

Do not use:

on large areas of the body
on cut, swollen or irritated skin
on open wounds
for longer than one week without consulting a health practitioner.

Discontinue use and consult a healthcare practitioner if:

you have skin irritation or signs of injury, such as redness, pain, swelling or blistering where product is applied
condition worsens
symptoms last longer than one week

When using this product:

use only as directed
read and follow directions on this label
do not apply bandage to affected area after use
do not apply heat after use; do not use with other topical products on the same area at the same time.

If pregnant or breastfeeding: consult a healthcare practitioner before use.

Keep out of reach of children.

If swallowed, seek medical help or contact the Poison Control Center immediately.

Suggested use:

Rub 1.1 grams (approximately ¼ tsp) of cream into the affected area as needed.

Other Ingredients: Purified Water, MSM (Methylsulfonymethane), Glyceryl Stearate and PEG-100 Stearate, Cetearyl Alcohol and Ceteareth 20, Glyceryl Dilaurate, Magnesium Sulfate, Glycerine, Propylene Glycol, Cannabidiol (CBD) (Hemp Flower Extract), Isopropyl Mytistate, Cannabigerol (CBG) (Hemp Flower Extract), Guar Gum, Imidazolidinyl Urea, Methylparaben, Propylparaben

PRINCIPAL DISPLAY PANEL

HEMPTOWN
USA

JOINT & MUSCLE
CREAM

1128MG CBD
552MG CBG

HEMP OIL
EXTRACT

Net 4 fl oz
92 GRAMS

13.5 mg CBD per serving

6.6 mg CBG per serving

FREE OF Milk, Eggs, Fish, Shellfish, Peanuts or Wheat.

HEMP
TOWN
USA

SOURCED

NDC# 58223-908-01

The FDA has not evaluated this
product for safety or efficacy

6400 Rosewood Street
Lake Oswego, OR 97035
(800) 245-8282
HEMPTTOWNUSA.COM

JOINT AND MUSCLE CREAM
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58223-908
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	1.8 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Glyceryl Dilaurate (UNII: MFL3ZIE8SK)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Cannabidiol (UNII: 19GBJ60SN5)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Cannabigerol (UNII: J1K406072N)
Guar Gum (UNII: E89I1637KE)
Imidurea (UNII: M629807ATL)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 58223-908-01	1 in 1 CARTON	03/22/2021	12/15/2021
1		118.294 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/22/2021	12/15/2021

Labeler - HTO Nevada Inc. (117115846)

Revised: 12/2021

Document Id: 2a34015b-d08e-4e94-8a84-181295a1bbe1

Set id: 875ca64f-adb2-4599-bcc0-c1cf95a254c0

Version: 3

Effective Time: 20211215