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NDC 73287-0022-01 Hempvana Maximum Strength Pain Relief 10 g/100g Details

Hempvana Maximum Strength Pain Relief 10 g/100g

Hempvana Maximum Strength Pain Relief is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by TELEBRANDS CORP. The primary component is TROLAMINE SALICYLATE.

Product Information

NDC	73287-0022
Product ID	73287-022_d91a0fad-a38d-1580-e053-2a95a90ad268
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	Hempvana Maximum Strength Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Trolamine Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	g/100g
Substance Name	TROLAMINE SALICYLATE
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 73287-0022-01 (73287002201)

Pricing Information	N/A
NDC Package Code	73287-022-01
Billing NDC	73287002201
Package	1 APPLICATOR in 1 CARTON (73287-022-01) / 71 g in 1 APPLICATOR
Marketing Start Date	2022-02-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d91a0fad-a38c-1580-e053-2a95a90ad268 Details

Active Ingredient

Trolamine Salicylate 10%

Purpose

Trolamine Salicylate 10%..................Topical Analgesic

Uses

temporarily relieves minor pain associated with:

arthritis
simple backache
muscle strains
sprains
bruises

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, Ethylhexyl Stearate, Butylene Glycol, Caprylic/Capric Triglyceride, Dimethicone, Cannabis Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Stearic Acid, Tocopheryl Acetate, Allantoin, Phenoxyethanol, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Disodium EDTA, Citric Acid, Sodium Hydroxide

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

Maximum Strength Pain Relief Lotion

Odor Free!

New! 5 Deep Massaging Stainless Steel Rollerballs

Original

+Hemp Seed Oil

For Moisturization

Trolamine Salicylate 10% For Pain

Net Wt. 2.5 OZ (71 g)

INGREDIENTS AND APPEARANCE

HEMPVANA MAXIMUM STRENGTH PAIN RELIEF

trolamine salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73287-022
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALLANTOIN (UNII: 344S277G0Z)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DIMETHICONE (UNII: 92RU3N3Y1O)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73287-022-01	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(73287-022)

Revised: 2/2022

Document Id: d91a0fad-a38d-1580-e053-2a95a90ad268

Set id: d91a0fad-a38c-1580-e053-2a95a90ad268

Version: 1

Effective Time: 20220228