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NDC 73287-0016-01 Hempvana Ultra Strength Pain Relief Cream 4 g/100g Details

Hempvana Ultra Strength Pain Relief Cream 4 g/100g

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

Product Information

NDC	73287-0016
Product ID	73287-016_c315e185-df06-5de0-e053-2995a90acf37
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine 4%
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/100g
Substance Name	LIDOCAINE
Labeler Name	Telebrands Corp
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 73287-0016-01 (73287001601)

Pricing Information	N/A
NDC Package Code	73287-016-01
Billing NDC	73287001601
Package	1 JAR in 1 CARTON (73287-016-01) / 119 g in 1 JAR
Marketing Start Date	2021-05-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c3162ba8-ac2d-5a65-e053-2995a90af246 Details

Active Ingredient

Lidocaine 4%

Purpose

Lidocaine 4%..................Topical Analgesic

Uses

For the temporary relief of minor aches and pains.

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
Apply generously to affected area.
Massage into painful area until thoroughly absorbed into skin.
Repeat as necessary, but no more than 4 times daily.

Inactive Ingredients

Water/Aqua/Eau, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Cannabis Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide, Disodium EDTA, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Blue 1 (CI 42090), Yellow 5 (CI 19140)

Questions?

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

PRINCIPAL DISPLAY PANEL

Hempvana

Ultra Strength

Pain Relief

Cream

with 4% Lidocaine

+ Hemp Seed Oil

Odor Free!

Net Wt. 4 OZ (119 g)

INGREDIENTS AND APPEARANCE

HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM

lidocaine 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73287-016
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARIC ACID (UNII: 4ELV7Z65AP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TURMERIC (UNII: 856YO1Z64F)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73287-016-01	1 in 1 CARTON	05/24/2021
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	05/24/2021

Labeler - Telebrands Corp (177266558)

Name	Address	ID/FEI	Business Operations
Establishment
Neutraderm, Inc.		146224444	manufacture(73287-016)

Revised: 5/2021

Document Id: c315e185-df06-5de0-e053-2995a90acf37

Set id: c3162ba8-ac2d-5a65-e053-2995a90af246

Version: 1

Effective Time: 20210524