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NDC 73287-0018-01 Hempvana Ultra Strength Pain Relief Cream - Deep Heat 0.1 g/100g Details

Hempvana Ultra Strength Pain Relief Cream - Deep Heat 0.1 g/100g

Hempvana Ultra Strength Pain Relief Cream - Deep Heat is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Telebrands Corp. The primary component is CAPSAICIN.

Product Information

NDC	73287-0018
Product ID	73287-018_cf835039-a13b-3403-e053-2a95a90ab016
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 Ultra Strength Pain Relief Cream - Deep Heat
Proprietary Name Suffix	n/a
Non-Proprietary Name	Capsaicin
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	0.1
Active Ingredient Units	g/100g
Substance Name	CAPSAICIN
Labeler Name	Telebrands Corp
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 73287-0018-01 (73287001801)

Pricing Information	N/A
NDC Package Code	73287-018-01
Billing NDC	73287001801
Package	1 JAR in 1 CARTON (73287-018-01) / 119 g in 1 JAR
Marketing Start Date	2021-10-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cf835039-a13a-3403-e053-2a95a90ab016 Details

Active ingredient

Capsaicin 0.1%

Purpose

Capsaicin 0.1%.......................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.
Children under 2 years of age: consult a physician.

Inactive ingredients

Water/Aqua/Eau, Isopropyl Myristate, Stearic Acid, Cetyl Alcohol, Glycerin, Petrolatum, Ethoxydiglycol, Cannabis Sativa (Hemp) Seed Oil, Potassium Cetyl Phosphate, Tocopheryl Acetate, Phenoxyethanol, Sodium Hydroxide, Disodium EDTA, Ethylhexylglycerin, Red 4 (CI 14700), Blue 1 (CI 42090), Yellow 5 (CI 19140)

Questions?

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

PRINCIPAL DISPLAY PANEL

Hempvana Brand

Ultra Strength Pain Relief Cream

Deep Heat

+ Hemp Seed Oil

For Moisturization

Capsaicin 0.1%

For Pain

Net Wt. 4oz (119 g)

INGREDIENTS AND APPEARANCE

HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM - DEEP HEAT

capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73287-018
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PETROLATUM (UNII: 4T6H12BN9U)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73287-018-01	1 in 1 CARTON	10/29/2021
1		119 g in 1 JAR; 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	10/29/2021

Labeler - Telebrands Corp (177266558)

Name	Address	ID/FEI	Business Operations
Establishment
Neutraderm, Inc.		146224444	manufacture(73287-018)

Revised: 10/2021

Document Id: cf835039-a13b-3403-e053-2a95a90ab016

Set id: cf835039-a13a-3403-e053-2a95a90ab016

Version: 1

Effective Time: 20211029