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NDC 73287-0024-01 Hempvana Ultra Strength Pain Relief 4 g/100g Details

Hempvana Ultra Strength Pain Relief 4 g/100g

Hempvana Ultra 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 LIDOCAINE.

Product Information

NDC	73287-0024
Product ID	73287-024_d91ba9b1-0840-32e9-e053-2a95a90a9bd1
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
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 73287-0024-01 (73287002401)

Pricing Information	N/A
NDC Package Code	73287-024-01
Billing NDC	73287002401
Package	1 APPLICATOR in 1 CARTON (73287-024-01) / 71 g in 1 APPLICATOR
Marketing Start Date	2022-02-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d91ba9b1-083f-32e9-e053-2a95a90a9bd1 Details

Active Ingredient

Lidocaine 4%

Purpose

Lidocaine 4%....................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., Glycerin, Dimethicone, Glyceryl Stearate, Caprylyl Methicone, Cannabis Sativa (Hemp) Seed Oil, Ceteth-20 Phosphate, Cetearyl Alcohol, Squalane, Tocopheryl Acetate, Phenoxyethanol, C30-45 Alkyl Cetearyl, Dimethicone Crosspolymer, Dicetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Polysorbate 60, Disodium EDTA, Aminomethyl Propanol, 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

Odor Free!

New! 5 Deep Massaging Stainless Steel Rollerballs

With 4% Lidocaine For Pain

+Hemp Seed Oil For Moisturization

Net Wt. 2.5 OZ (71 g)

INGREDIENTS AND APPEARANCE

HEMPVANA ULTRA STRENGTH PAIN RELIEF

lidocaine lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73287-024
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
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
SQUALANE (UNII: GW89575KF9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73287-024-01	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(73287-024)

Revised: 2/2022

Document Id: d91ba9b1-0840-32e9-e053-2a95a90a9bd1

Set id: d91ba9b1-083f-32e9-e053-2a95a90a9bd1

Version: 1

Effective Time: 20220228