DailyMed - HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM PLATINUM 4% LIDOCAINE- lidocaine 4% cream

NDC Code(s): 73287-042-01
Packager: Telebrands Corp

Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 21, 2024

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Active Ingredient
Lidocaine 4%

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

Lidocaine 4%..................Topical Analgesic
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Uses
For the temporary relief of pain

For the temporary relief of pain
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Warnings
For external use only - Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. Do Not Use - in large quantities, particularly over raw ...
For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Do Not Use
- in large quantities, particularly over raw surfaces or blistered areas
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.

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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 ...
- 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.
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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 ...

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

Questions? Call (855) 877-4503 (M-F, 9am-5pm EST)
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PRINCIPAL DISPLAY PANEL (What is this?)
Hempvana - Ultra Strength - Pain Relief - Cream - Platinum - with 4% Lidocaine - +4xHemp Seed Oil for moisturization - Net Wt. 3 OZ (85 g)

Hempvana

Ultra Strength

Pain Relief

Cream

Platinum

with 4% Lidocaine

+4xHemp Seed Oil for moisturization

Net Wt. 3 OZ (85 g)

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INGREDIENTS AND APPEARANCE

Product Information

HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM PLATINUM 4% LIDOCAINE lidocaine 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73287-042
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 YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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:73287-042-01	1 in 1 CARTON	11/21/2024
1		85 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 Drug	M017	11/21/2024

Labeler - Telebrands Corp (177266558)

Name	Address	ID/FEI	Business Operations
Establishment
Neutraderm, Inc.		146224444	manufacture(73287-042)

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Label: HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM PLATINUM 4% LIDOCAINE- lidocaine 4% cream

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Label: HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM PLATINUM 4% LIDOCAINE- lidocaine 4% cream

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Safety

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Safety

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HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM PLATINUM 4% LIDOCAINE- lidocaine 4% cream

Number of versions: 1

HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM PLATINUM 4% LIDOCAINE- lidocaine 4% cream

HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM PLATINUM 4% LIDOCAINE- lidocaine 4% cream

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HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM PLATINUM 4% LIDOCAINE- lidocaine 4% cream

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.