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NDC 39765-0011-01 Hempvana 10 g/100g Details

Hempvana 10 g/100g

Hempvana is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Neutraderm, Inc.. The primary component is TROLAMINE SALICYLATE.

Product Information

NDC	39765-0011
Product ID	39765-011_2e202a4c-12d0-4b5c-9392-4387a275c4cc
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
Proprietary Name Suffix	Pain Relief
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	Neutraderm, Inc.
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 39765-0011-01 (39765001101)

Pricing Information	N/A
NDC Package Code	39765-011-01
Billing NDC	39765001101
Package	1 JAR in 1 CARTON (39765-011-01) / 119 g in 1 JAR
Marketing Start Date	2019-01-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d3dc9108-5182-482b-8be5-f33b1b3e3813 Details

Drug Facts

Active Ingredient:

Trolamine Salicylate (10%)

Purpose

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

For Use By Adults Only
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, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Cannabis Sativa Seed Oil (Hemp Seed Oil), Glyceryl Stearate, PEG-100 Stearate, Cetostearyl Alcohol, Sunflower Oil, Allantoin, Tocopheryl Acetate, Ethylhexylglycerin, Isohexadecane,

Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Hexylene Glycol, Polysorbate 80, Disodium EDTA, D&C Green No. 5 (CI 61570), Sodium Hydroxide, Phenoxyethanol

Questions?

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

SPL UNCLASSIFIED SECTION

MAXIMUM STRENGTH

Enriched With Hemp Seed* Extract

ODOR FREE!

Phthalate Free Paraben Free Vegan Gluten Free Cruelty Free

• No Irritation • No Burning • Non Greasy

Hempvana® Pain Relief Cream absorbs quickly and goes to work instantly. Its unique formula includes a proven active ingredient plus the moisturizing benefit of cold pressed hemp seed* extract for soothing relief to back, neck, shoulders, feet, wrists, calves and more.

TAMPER EVIDENT: Do not use if safety seal on cap is broken or missing.

For more information, visit www.HempvanaStore.com

*Complies with Federal Law. Hemp seed extract contains no detectible tetrahydrocannabinol (THC) or cannabidiol (CBD), Derived from the cannabis industrial hemp cultivar.

Dist. by: Telebrands Corp.

79 Two Bridges Road,

Fairfield, NJ 07004

Hemp • Health • HappinessTM

Packaging

INGREDIENTS AND APPEARANCE

HEMPVANA PAIN RELIEF

trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:39765-011
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
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)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOHEXADECANE (UNII: 918X1OUF1E)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	green (Pale Green to Light Green)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:39765-011-01	1 in 1 CARTON	01/10/2019
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	01/10/2019

Labeler - Neutraderm, Inc. (146224444)

Name	Address	ID/FEI	Business Operations
Establishment
Neutraderm, Inc.		146224444	manufacture(39765-011)

Revised: 6/2019

Document Id: 2e202a4c-12d0-4b5c-9392-4387a275c4cc

Set id: d3dc9108-5182-482b-8be5-f33b1b3e3813

Version: 2

Effective Time: 20190618