Pain Relieving Cold Therapy

Pain Relieving Cold Therapy
SPL v2
SPL
SPL Set ID de210c3a-c24e-cefd-e053-2a95a90a93ff
Route
TOPICAL
Published
Effective Date 2022-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g)
Inactive Ingredients
Glycerin Ilex Paraguariensis Leaf Peppermint Oil Boswellia Serrata Whole Arnica Montana Flower Eucalyptus Oil Dimethyl Sulfone Water Alcohol Trolamine (c10-c30)alkyl Methacrylate Ester

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-01-01

Description

Menthol USP 10.0%

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

Menthol USP 10.0%

Pdp

CryoDerm

Pain Relieving Cold Therapy

Gel

Fast Acting, Penetrating Pain Relief For:

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

Contains Essential Oils and Natural Extracts

MSM Arnica Boswellia Ilex

Active Ingredient: Menthol

1 Gallon 128 fl. oz 4.2L

Uses

Temporarily relieves minor minor aches and pains associated with

  • sore musclkes and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises
Warnings

For external use only

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, Boswella Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone(MSM), Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine

When Using This Product

Use only as directed

Do not bandage or cover the area being treated

Do not apply ice or heating pad in conjunction with this product

Do not use with any medical device or any other device

Do not combine with any other topical treatments

Avoid contact with eyes or mucous membrane

Do not apply to wounds or damaged skin

If Pregnant Or Breast Feeding

Ask a healthcare professional before use

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:

Conditions worsens or symptoms persist for more than 7 days or clear up and recur

  • Redness if present or irritation develops
Directions Adults and Children 2 Years of Age and Older

Massage a liberal amount of gel 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


Structured Label Content

Pdp (PDP)

CryoDerm

Pain Relieving Cold Therapy

Gel

Fast Acting, Penetrating Pain Relief For:

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

Contains Essential Oils and Natural Extracts

MSM Arnica Boswellia Ilex

Active Ingredient: Menthol

1 Gallon 128 fl. oz 4.2L

Uses

Temporarily relieves minor minor aches and pains associated with

  • sore musclkes and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises
Purpose

Pain Reliever

Warnings

For external use only

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

Acrylates, Arnica, Boswella Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone(MSM), 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 cover the area being treated

Do not apply ice or heating pad in conjunction with this product

Do not use with any medical device or any other device

Do not combine with any other topical treatments

Avoid contact with eyes or mucous membrane

Do not apply to wounds or damaged skin

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

Ask a healthcare professional before use

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:)

Conditions worsens or symptoms persist for more than 7 days or clear up and recur

  • Redness if present or irritation develops
Directions Adults and Children 2 Years of Age and Older (Directions - Adults and children 2 years of age and older)

Massage a liberal amount of gel 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


Advanced Ingredient Data


Raw Label Data

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