Cryoderm Heat Warming Lotion

Cryoderm Heat Warming Lotion
SPL v5
SPL
SPL Set ID 27679d31-a5f3-417b-b0c5-5f6b001ecff9
Route
TOPICAL
Published
Effective Date 2015-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (77.3645 mL) Camphor (synthetic) (0.5 mL) Capsaicin (0.4 mL)
Inactive Ingredients
Water Aloe Vera Leaf Arnica Montana Boswellia Serrata Whole 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, Dl- Trolamine Yucca Schidigera

Identifiers & Packaging

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

Description

Adults and children 2 years and older: Massage a small amount of lotion directly on the skin over the affected area. Repeat as necessary but do not apply more than 4 times daily. Children under 2 years of age : Consult a Physician

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

Adults and children 2 years and older: Massage a small amount of lotion directly on the skin over the affected area. Repeat as necessary but do not apply more than 4 times daily. Children under 2 years of age : Consult a Physician

Section 51945-4

CryoDerm

HEAT

PAIN RELIEVING

WARM Therapy

Lotion



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



16 fl.oz. 449mL

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:

Massage a small amount of lotion directly on the skin over the affected area. 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 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

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

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

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

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


Structured Label Content

Section 51945-4 (51945-4)

CryoDerm

HEAT

PAIN RELIEVING

WARM Therapy

Lotion



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



16 fl.oz. 449mL

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:

Massage a small amount of lotion directly on the skin over the affected area. Repeat as necessary but do not apply more than 4 times daily.

Children under 2 years of age: Consult a Physician

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

inactive Ingredients (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

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

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

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


Advanced Ingredient Data


Raw Label Data

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