Cramp Calm Muscle Pain Relief Foam: Package Insert and Label Information

CRAMP CALM MUSCLE PAIN RELIEF FOAM- trolamine salicylate aerosol, foam
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.

Trolamine Salicylate 10%

Purpose

Trolamine Salicylate 10%……………………Topical Analgesic

Uses

temporarily releaves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

Warnings

For external use only

When using this product

  • Avoid contact with eyes
  • Use only as directed
  • Do not ingest
  • Consult a physician before using if you have a skin condition
  • Do not apply to wounds or damaged skin
  • Do not bandage tightly

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
  • Unintended effects occur

If pregnant or breastfeeding , ask a health care professional before using.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults: Apply 2 pumps of foam on the affected muscles. Rub in until absorbed. Allow to air dry. Use as needed.

For children under 12 years of age: Consult a physician.

Other information

  • Store between 32 degrees F and 120 degrees F

Inactive ingredients

Water/Aqua/Eau, Decyl Glucoside, Magnesium Sulfate, Dimethyl Sulfone, Hemp Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Aloe Barbadensis Leaf Juice, Curcuma Longa (Turmeric) Root Extract, Arnica Montana Flower Extract, Phenoxyethanol, Sodium Citrate, Citric Acid, Ethylhexylglycerin, Disodium EDTA, Sodium Hydroxide

Questions?

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

With FOAM TECHNOLOGY

NDC 73287-006-01

#1 Hemp Brand in America 1

Cramp Calm(tm)

MUSCLE PAIN RELIEF FOAM

Enriched with Moisturizing Benefits of Hemp Seed Oil Turmeric and Aloe

Trolamine Salicylate 10%

  • Calves
  • Feet
  • Legs

1 AC NIELSEN report on file

Patent Pending

7 fl oz (207 mL)

LOT #

EXP.

Cramp Calm
(click image for full-size original)
CRAMP CALM MUSCLE PAIN RELIEF FOAM
trolamine salicylate 10% aerosol, foam
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73287-006
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TROLAMINE SALICYLATE (SALICYLIC ACID) TROLAMINE SALICYLATE 10 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
PHENOXYETHANOL
SODIUM CITRATE
ETHYLHEXYLGLYCERIN
EDETATE DISODIUM ANHYDROUS
CITRIC ACID MONOHYDRATE
ALOE VERA LEAF
WATER
DIMETHYL SULFONE
CANNABIS SATIVA SEED OIL
SODIUM HYDROXIDE
DECYL GLUCOSIDE
MAGNESIUM SULFATE, UNSPECIFIED FORM
SAFFLOWER OIL
TURMERIC
ARNICA MONTANA FLOWER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73287-006-01 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 207 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (73287-006-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/24/2020
Labeler — Telebrands Corp (177266558)
Establishment
Name Address ID/FEI Operations
Neutraderm, Inc. 146224444 manufacture (73287-006)

Revised: 01/2020 Telebrands Corp

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