CANNESSENTIA PAIN RELIEF CREAM- 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:
CannEssentia LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - sprains - bruises - cramps
Authorization status:
OTC monograph not final
Authorization number:
72418-333-15

CANNESSENTIA PAIN RELIEF CREAM- trolamine salicylate cream

CannEssentia LLC

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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CannEssentia Pain Relief Cream

Active ingredient

Trolamine salicylate 10%

Purpos e

Topical analgesic

Us es

For the temporary relief of minor aches and pains of muscles and joints associated with:

simple backache

arthritis

strains

sprains

bruises

cramps

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 last for more than 7 days or clear up and occur again within a few days

redness is present

irritation develops

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years:

apply generously to affected area

massage into painful area until thoroughly absorbed into skin

repeat as necessary, but not more than 3to 4 times daily

children 12 years and younger: ask a doctor

Inactive ingredients

coconut oil, cod liver oil (contains vitamin A & vitamin D), fragrances, hemp seed oil, lanolin, light

mineral oil, medium-chain triglycerides, microcrystalline wax, paraffin, petrolatum, sodium chloride,

terpene essential oil, yellow wax

Principal Display Panel

NDC # 72418-333-15

CannEssentia

Pain Relief Cream

(Trolamine Salicylate)

NET WT 0.5 OZ (14.17 g)

CANNESSENTIA PAIN RELIEF CREAM

trolamine salicylate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:72418 -333

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

CannEssentia LLC

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

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

CO D LIVER O IL (UNII: BBL28 1NWFG)

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

LANO LIN (UNII: 7EV6 5EAW6 H)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

PARAFFIN (UNII: I9 O0 E3H2ZE)

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:72418 -333-

1 in 1 CARTON

0 3/0 1/20 19

1

14.17 g in 1 VIAL, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

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 3/0 1/20 19

Labeler -

CannEssentia LLC (031775148)

Revised: 12/2019

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