ULTRA STRENGTH PAIN RELIEF GEL- menthol lotion

Ultra Strength Pain Relief Gel by

Drug Labeling and Warnings

Ultra Strength Pain Relief Gel by is a Otc medication manufactured, distributed, or labeled by TELEBRANDS CORP, Neutraderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 8%

Purpose

Menthol 8%....................Topical Analgesic

Uses

For the temporary relief of pain

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

• Use only as directed. Read and follow all directions and warnings on this label.
• Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
• Avoid contact with eyes or mucous membranes.
• Do not apply to wounds or damaged, broken or irritated skin.
• Do not use at the same time as other topical analgesics.

Stop use and ask a doctor if

• Condition worsens
• Symptoms persist for more than 7 days or clear up and occur again within a few days
• Redness is present or irritation develops

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily using roller ball applicator
• Children under 2 years of age: consult a physician

Inactive Ingredients

Water/Aqua/Eau, Alcohol Denat., Isopropyl Myristate, Cannabis Sativa (Hemp) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Ilex Paraguariensis Leaf Extract, Arnica Montana Flower Extract,, Melissa Officinalis (Balm Mint) Extract, Camphor, Phenoxyethanol, Glycerin, Carbomer, Ethylhexylglycerin, Sodium Hydroxide, Disodium EDTA, Tocopheryl Acetate, Silica, Yellow 5 (CI 19140), Blue 1 (CI 42090)

Questions?

Call (855) 877-4503 (M-F, 9am-5pm EST)

PRINCIPAL DISPLAY PANEL

#1 Hemp Pain Relief Brand in America 1

1AC Nielsen 2021 food drug mass POS

Hempvana Brand

Ultra Strength Pain Relief Lotion

NEW! 5 Deep Massaging Stainless Steel Rollerballs

Arthritis

+ Hemp Seed Oil For Moisturization

Menthol 8% For Pain

Net Wt. 2.5 OZ (71g)

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH PAIN RELIEF GEL 
menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73287-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MELISSA OFFICINALIS (UNII: YF70189L0N)
TURMERIC (UNII: 856YO1Z64F)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73287-023-01	1 in 1 CARTON	02/28/2022
1		71 g in 1 APPLICATOR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/28/2022

Labeler - TELEBRANDS CORP (177266558)

Establishment
Name	Address	ID/FEI	Business Operations
Neutraderm, Inc.		146224444	manufacture(73287-023)