Hempvana Maximum Strength Pain Relief Cream

Hempvana Maximum Strength Pain Relief Cream by

Drug Labeling and Warnings

Hempvana Maximum Strength Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by Telebrands Corp, Neutraderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEMPVANA MAXIMUM STRENGTH PAIN RELIEF CREAM- lidocaine 4% cream 
Telebrands Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hempvana Maximum Strength Pain Relief Cream

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)

Hempvana

Maximum Strength

Pain Relief Cream

with 4% Lidocaine

+ Hemp Seed Oil

Odor Free!

Net Wt. 4 OZ (119 g)

HEMPVANA MAXIMUM STRENGTH PAIN RELIEF CREAM 
lidocaine 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73287-013
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73287-013-01	1 in 1 CARTON	05/12/2021
1		119 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/12/2021	12/31/2021

Labeler - Telebrands Corp (177266558)

Establishment
Name	Address	ID/FEI	Business Operations
Neutraderm, Inc.		146224444	manufacture(73287-013)

Revised: 5/2021

Document Id: c32f5767-77ea-e83f-e053-2995a90a5690

34390-5

Set id: c229841c-ade3-6230-e053-2995a90a7d94

Version: 2

Effective Time: 20210525