CBDRelief Pain Relief Body: Package Insert and Label Information

CBDRELIEF PAIN RELIEF BODY- trolamine salicylate lotion
Nutritech Pharmaceuticals, Inc.

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.

Trolamine Salicylate 10%

Purpose

Trolamine Salicylate 10%……..Topical Analgesic

Uses

Temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps

Warnings

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
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucos membranes
  • do not apply to wounds or damaged skin

Stop use and ask doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present n irritation develops

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Keep out of reach of children

Keep out of reach of children.

Directions

Directions

Adults and children over 12 years of age:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

Children 12 years or younger: ask a doctor

Inactive Ingredients

Inactive Ingredients

Purified Water, CBD Hemp Oil, Stearic Acid, Cetyl Alcohol, Glyceryl Stearate, Aloe Vera, Triethanolamine, Dimethicone, Propyl Paraben, Methylparaben, Carbomer, Iodopropynyl Butylcarbamate

Label
(click image for full-size original)

CBDRELIEF PAIN RELIEF BODY
trolamine salicylate 10% lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73529-250
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
METHYLPARABEN
CARBOMER 940
CETYL ALCOHOL
TRIETHANOLAMINE OLEATE
WATER
STEARIC ACID
GLYCERYL STEARATE CITRATE
ALOE VERA LEAF
HEMP
IODOPROPYNYL BUTYLCARBAMATE
DIMETHICONE 100
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73529-250-01 1 TUBE in 1 CARTON contains a TUBE
1 40 g in 1 TUBE This package is contained within the CARTON (73529-250-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/11/2020
Labeler — Nutritech Pharmaceuticals, Inc. (117342868)

Revised: 02/2020 Nutritech Pharmaceuticals, Inc.

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