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%

Purpose

Topical analgesic

Uses

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

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:

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)

box

CANNESSENTIA PAIN RELIEF CREAM 
trolamine salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72418-333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCONUT OIL (UNII: Q9L0O73W7L)  
COD LIVER OIL (UNII: BBL281NWFG)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
LANOLIN (UNII: 7EV65EAW6H)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72418-333-151 in 1 CARTON03/01/2019
114.17 g in 1 VIAL, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2019
Labeler - CannEssentia LLC (031775148)

Revised: 12/2019
Document Id: 99fd0d1b-1687-cdee-e053-2995a90af9d5
Set id: 7aa261d1-15a2-e0ab-e053-2a91aa0ad2a0
Version: 2
Effective Time: 20191218
 
CannEssentia LLC