Cryoderm Cold Therapy Roll On

Cryoderm Cold Therapy Roll On
SPL v4
SPL
SPL Set ID 52fff03e-eba2-4604-a71c-2522468f627b
Route
TOPICAL
Published
Effective Date 2022-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 mL)
Inactive Ingredients
Arnica Montana Flower Boswellia Serrata Whole Eucalyptus Oil Glycerin Ilex Paraguariensis Leaf Dimethyl Sulfone Peppermint Oil Water Alcohol Trolamine (c10-c30)alkyl Methacrylate Ester

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-01-01

Description

Temporary relieves minor aches and pains associated with sore muscles and joints arthritis backache muscle strains sprains bruises

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

Temporary relieves minor aches and pains associated with sore muscles and joints arthritis backache muscle strains sprains bruises

Pdp

CryoDerm

Pain Relieving Cold Therapy

Roll-on

Fast Acting, Penetrating, Pain Relief For:

Muscle Strains, Joint Pain, Backache, Arthritis, Sprained Ligaments & Bruises.

Contains Essential Oils and Natural Extracts

MSM Arnica Boswellia Ilex

Active Ingredient: Menthol

3 fl. oz. 95 mL

uses

Temporary relieves minor aches and pains associated with

  • sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises
purpose

Pain Reliever

warnings

For external use only

directions

Adults and children 2 years and older: 

Apply directly onto afected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more than 4 times daily.

Children under 2 years of age: Consult a Physician

Active Ingredient

Menthol USP 10.0%

other Information:

Store in a cool dry place with lid or cap closed tightly

Flammable: Keep away from excessive heat or open flame

inactive Ingredients:

Acrylates, Arnica, Boswellia Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone, Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine

when Using This Product:

Use only as directed. Do not bandage or use a heating pad or device. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not use with other ointment, creams, sprays or liniments. After applying wash hands thoroughly with cool water

stop Use and Ask Doctor If:

Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritation develops

keep Out of Reach of Children

In case of accidental ingestion get medical help or contact a Poison Control Center immediately

if Pregnant Or Breast Feeding:

Consult a health professional before use


Structured Label Content

Pdp (PDP)

CryoDerm

Pain Relieving Cold Therapy

Roll-on

Fast Acting, Penetrating, Pain Relief For:

Muscle Strains, Joint Pain, Backache, Arthritis, Sprained Ligaments & Bruises.

Contains Essential Oils and Natural Extracts

MSM Arnica Boswellia Ilex

Active Ingredient: Menthol

3 fl. oz. 95 mL

uses (Uses)

Temporary relieves minor aches and pains associated with

  • sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises
purpose (Purpose)

Pain Reliever

warnings (Warnings)

For external use only

directions (Directions)

Adults and children 2 years and older: 

Apply directly onto afected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more than 4 times daily.

Children under 2 years of age: Consult a Physician

Active Ingredient

Menthol USP 10.0%

other Information: (Other Information:)

Store in a cool dry place with lid or cap closed tightly

Flammable: Keep away from excessive heat or open flame

inactive Ingredients: (Inactive Ingredients:)

Acrylates, Arnica, Boswellia Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone, Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine

when Using This Product: (When using this product:)

Use only as directed. Do not bandage or use a heating pad or device. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not use with other ointment, creams, sprays or liniments. After applying wash hands thoroughly with cool water

stop Use and Ask Doctor If: (Stop use and ask doctor if:)

Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritation develops

keep Out of Reach of Children (Keep Out of Reach of Children)

In case of accidental ingestion get medical help or contact a Poison Control Center immediately

if Pregnant Or Breast Feeding: (If Pregnant or Breast Feeding:)

Consult a health professional before use


Advanced Ingredient Data


Raw Label Data

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