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NDC 73287-0023-01 Ultra Strength Pain Relief Gel 8 g/100g Details

Ultra Strength Pain Relief Gel 8 g/100g

Ultra Strength Pain Relief Gel is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by TELEBRANDS CORP. The primary component is MENTHOL.

Product Information

NDC	73287-0023
Product ID	73287-023_d91b2e09-550f-4968-e053-2995a90ae323
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Ultra Strength Pain Relief Gel
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	8
Active Ingredient Units	g/100g
Substance Name	MENTHOL
Labeler Name	TELEBRANDS CORP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 73287-0023-01 (73287002301)

Pricing Information	N/A
NDC Package Code	73287-023-01
Billing NDC	73287002301
Package	1 APPLICATOR in 1 CARTON (73287-023-01) / 71 g in 1 APPLICATOR
Marketing Start Date	2022-02-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d91b2e09-550e-4968-e053-2995a90ae323 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/28/2022

Labeler - TELEBRANDS CORP (177266558)

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

Revised: 2/2022

Document Id: d91b2e09-550f-4968-e053-2995a90ae323

Set id: d91b2e09-550e-4968-e053-2995a90ae323

Version: 1

Effective Time: 20220228