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NDC 73287-0021-01 Hempvana Maximum Strength Pain Relief - Platinum 10 g/100g Details

Hempvana Maximum Strength Pain Relief - Platinum 10 g/100g

Hempvana Maximum Strength Pain Relief - Platinum is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by TELEBRANDS CORP. The primary component is TROLAMINE SALICYLATE.

Product Information

NDC	73287-0021
Product ID	73287-021_d58da6c5-47a7-b8a8-e053-2995a90a7ce7
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 Maximum Strength Pain Relief - Platinum
Proprietary Name Suffix	n/a
Non-Proprietary Name	Trolamine salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	g/100g
Substance Name	TROLAMINE SALICYLATE
Labeler Name	TELEBRANDS CORP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 73287-0021-01 (73287002101)

Pricing Information	N/A
NDC Package Code	73287-021-01
Billing NDC	73287002101
Package	1 JAR in 1 CARTON (73287-021-01) / 119 g in 1 JAR
Marketing Start Date	2022-01-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d58da6c5-47a6-b8a8-e053-2995a90a7ce7 Details

Active ingredient

Trolamine Salicylate 10%

Purpose

Trolamine Salicylate 10%..........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
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, Cannabis Sativa (Hemp) Seed Oil, Butylene Glycol, Stearic Acid, DImethicone, Caprylic/Capric Trigylceride, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Glycerin, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Curcuma Longa (Turmeric) Root Extract, Dimethyl Sulfone, Tocopheryl Acetate, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Isohexadecane, Ethylhexylglycerin, Hexylene Glycol, Allantoin, Mannitol, Microcrystalline Cellulose, Iron Oxides Yellow (CI 77492), Tocopherol, Hydroxypropyl Methylcellulose, Ubiquinone, Polysorbate 80, Sodium Hydroxide, Disodium EDTA, Yellow 6 (CI 15985), Blue 1 (CI 42090)

Questions?

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

PRINCIPAL DISPLAY PANEL

Hempvana

Maximum Strength Pain Relief Cream

Platinum

+4x Hemp* Seed Oil

For Moisturization

Trolamine Salicylate 10%

For Pain

Net Wt. 4 oz (119 g)

*Compared to original Hempvana Pain Relief Cream

INGREDIENTS AND APPEARANCE

HEMPVANA MAXIMUM STRENGTH PAIN RELIEF - PLATINUM

trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73287-021
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
TURMERIC (UNII: 856YO1Z64F)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
UBIDECARENONE (UNII: EJ27X76M46)
ALLANTOIN (UNII: 344S277G0Z)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
WATER (UNII: 059QF0KO0R)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PEG-100 STEARATE (UNII: YD01N1999R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73287-021-01	1 in 1 CARTON	01/14/2022
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	01/14/2022

Labeler - TELEBRANDS CORP (177266558)

Name	Address	ID/FEI	Business Operations
Establishment
Neutraderm, Inc.		146224444	manufacture(73287-021)

Revised: 1/2022

Document Id: d58da6c5-47a7-b8a8-e053-2995a90a7ce7

Set id: d58da6c5-47a6-b8a8-e053-2995a90a7ce7

Version: 1

Effective Time: 20220114