Cold Therapy
Cold Therapy Menthol Gel
90334420-5f81-4284-9a57-42e134ce362f
HUMAN OTC DRUG LABEL
Sep 2, 2025
AHC VENTURES CORP DBA CRYODERM
DUNS: 131871779
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Menthol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PDP
CryoDerm
Pain Relieving Cold Therapy
Gel
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
4 fl. oz. 126mL
INDICATIONS & USAGE SECTION
**Uses**
Temporary relieves minor aches and pains associated with
- sore muscles and joints
- arthritis
- backache
- muscle strains
- sprains
- bruises
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Menthol USP 10.0%
OTC - PURPOSE SECTION
**Purpose**
Pain Reliever
OTC - STOP USE SECTION
**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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
**Keep Out of Reach of Children:**
In case of accidental ingestion get medical help or contact a Poison Control Center immediately
WARNINGS SECTION
**Warnings:**
For external use only
OTC - WHEN USING SECTION
**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
DOSAGE & ADMINISTRATION SECTION
OTC - PREGNANCY OR BREAST FEEDING SECTION
**If Pregnant or Breast Feeding:**
Ask a health professional before use
OTHER SAFETY 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 INGREDIENT SECTION
**Inactive Ingredients:**
Acrylates, Arnica, Boswellia Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone, Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine
INSTRUCTIONS FOR USE SECTION
**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