Cryoderm Heat Warming Roll On

Cryoderm Heat Warming Roll On
SPL v4
SPL
SPL Set ID 799751f3-726a-42de-934e-dbc3cd1cb8b8
Route
TOPICAL
Published
Effective Date 2015-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.5 mL) Camphor (synthetic) (77.3645 mL) Capsaicin (0.4 mL)
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Boswellia Serrata Whole Water Green Tea Leaf Carbomer 940 Cetostearyl Alcohol Cetearyl Glucoside Citrus Aurantium Fruit Grapefruit Dimethyl Sulfone Ethylhexylglycerin Glycerin Ilex Paraguariensis Leaf Phenoxyethanol Rosa Canina Flower .alpha.-tocopherol Acetate, D- Trolamine Yucca Schidigera

Identifiers & Packaging

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

Description

For external use only

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

For external use only

Pdp

CryoDerm

HEAT



PAIN RELIEVING



WARMING Therapy

ROLL-ON

Fast, Deep Penetrating Pain Relief for:

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

Paraben Free / Propylene Glycol Free / Aspirin Free

NSAID Free / Silicone Dioxide Free / Gluten Free

Contains Essential Oils & Natural Extracts

MSM Arnica Boswellia Ilex



Active Ingredients:

Menthol . Camphor . Capsaicin

3 fl.oz. 84mL

uses

Temporary relieves minor aches and pains associated with

  • sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises
warnings:

For external use only

directions

Adults and children 2 years and older:

Apply a small amount directly on the skin over the affected 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

Inactive Ingredients

Aloe Vera, Arnica Extract, Boswellia Serrata Extract, Green Tea Extract, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Orange Fruit Extract, Grapefruit Extract, Dimethyl Sulfone, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis Leaf Extract, Phenoxyethanol, Purified Water, Rose Extract, Vitamin E, Triethanolamine, Yucca Extract

active Ingredient

Menthol USP 3.85%

Camphor USP 3.85%

Capsaicin USP 0.0355%

other Information

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

Flammable: Keep away from excessive heat or open flame

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

keep Out of Reach of Children

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

stop Use and Ask A Doctor If:

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

if Pregnant Or Breast Feeding:

Ask a health professional before use

this Product Contains Capsaicin

and may cause temporary burning, stinging, inflammation, redness or welts on the application site thatususally disappear in a few days. If you experience any of these symptoms discontinue use and contact your doctor immediately


Structured Label Content

Pdp (PDP)

CryoDerm

HEAT



PAIN RELIEVING



WARMING Therapy

ROLL-ON

Fast, Deep Penetrating Pain Relief for:

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

Paraben Free / Propylene Glycol Free / Aspirin Free

NSAID Free / Silicone Dioxide Free / Gluten Free

Contains Essential Oils & Natural Extracts

MSM Arnica Boswellia Ilex



Active Ingredients:

Menthol . Camphor . Capsaicin

3 fl.oz. 84mL

Purpose

Pain Reliever

uses (Uses)

Temporary relieves minor aches and pains associated with

  • sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises
warnings: (Warnings:)

For external use only

directions (Directions)

Adults and children 2 years and older:

Apply a small amount directly on the skin over the affected 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

Inactive Ingredients

Aloe Vera, Arnica Extract, Boswellia Serrata Extract, Green Tea Extract, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Orange Fruit Extract, Grapefruit Extract, Dimethyl Sulfone, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis Leaf Extract, Phenoxyethanol, Purified Water, Rose Extract, Vitamin E, Triethanolamine, Yucca Extract

active Ingredient (Active Ingredient)

Menthol USP 3.85%

Camphor USP 3.85%

Capsaicin USP 0.0355%

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

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

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

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

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

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

Ask a health professional before use

this Product Contains Capsaicin (This product contains Capsaicin)

and may cause temporary burning, stinging, inflammation, redness or welts on the application site thatususally disappear in a few days. If you experience any of these symptoms discontinue use and contact your doctor immediately


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)