HEMPVANA PAIN RELIEF- trolamine salicylate cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Telebrands Corp
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Trolamine Salicylate 10%................Topical Analgesic temporarily relieves minor pain associated with: • arthritis  • simple backache  • muscle strains  • sprains  • bruises
Authorization status:
OTC monograph not final
Authorization number:
73287-001-01

HEMPVANA PAIN RELIEF- trolamine salicylate 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.

----------

Hempvana Pain Relief Cream

Drug Facts

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

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

Ques tions ?

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

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.

Maximum Strength

Odor Free

Non-Irritating

No Burning

Non Greasy

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 in the form of oil made by cold-pressing

industrial hemp seeds.

cultivar.

Dist. by: Telebrands Corp.

79 Two Bridges Road,

Fairfield, NJ 07004

Packaging

Hempvana

Pain Relief

Cream

Maximum Strength

Trolamine Salicylate 10%

#1 Hemp Brand on TV

Odor Free!

Enrished with Hemp Seed Extract*

Phthalate Free

Paraben Free

Vegan

Gluten Free

®

Cruelty Free

As Seen On TV

Net Wt. 4 OZ (119 g)

HEMPVANA PAIN RELIEF

trolamine salicylate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7328 7-0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TRO LAMINE SALICYLATE (UNII: H8 O40 40 BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)

TROLAMINE SALICYLATE 10 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Telebrands Corp

ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

CANNABIS SATIVA SEED O IL (UNII: 6 9 VJ1LPN1S)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

ALLANTO IN (UNII: 344S277G0 Z)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

ISO HEXADECANE (UNII: 9 18 X1OUF1E)

SO DIUM ACRYLATE/SO DIUM ACRYLO YLDIMETHYLTAURATE CO PO LYMER ( 4 0 0 0 0 0 0 MW) (UNII:

1DXE3F3OZX)

CARBO MER CO PO LYMER TYPE A ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 71DD5V9 9 5L)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

HEXYLENE GLYCO L (UNII: KEH0 A3F75J)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

D&C GREEN NO . 5 (UNII: 8 J6 RDU8 L9 X)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7328 7-0 0 1-0 1

1 in 1 CARTON

0 1/10 /20 19

1

119 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 1/10 /20 19

Labeler -

T elebrands Corp (177266558)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Neutraderm, Inc.

146 224444

ma nufa c ture (7328 7-0 0 1)

Revised: 9/2019

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