CannEssentia Pain Relief Cream: Package Insert and Label Information

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.

Active ingredient

Trolamine salicylate 10%

Purpose

Topical analgesic

Uses

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)

box
(click image for full-size original)
CANNESSENTIA PAIN RELIEF CREAM
trolamine salicylate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72418-333
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TROLAMINE SALICYLATE (SALICYLIC ACID) TROLAMINE SALICYLATE 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
COCONUT OIL
COD LIVER OIL
CANNABIS SATIVA SEED OIL
LANOLIN
YELLOW WAX
LIGHT MINERAL OIL
MEDIUM-CHAIN TRIGLYCERIDES
MICROCRYSTALLINE WAX
PARAFFIN
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72418-333-15 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 14.17 g in 1 VIAL, GLASS This package is contained within the CARTON (72418-333-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/01/2019
Labeler — CannEssentia LLC (031775148)

Revised: 12/2019 CannEssentia LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.