Cold Therapy
Cryoderm Cold Therapy Roll On
52fff03e-eba2-4604-a71c-2522468f627b
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
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
INDICATIONS & USAGE SECTION
**Uses**
Temporary relieves minor aches and pains associated with
- sore muscles and joints
- arthritis
- backache
- muscle strains
- sprains
- bruises
OTC - PURPOSE SECTION
**Purpose**
Pain Reliever
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Menthol USP 10.0%
DOSAGE & ADMINISTRATION SECTION
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
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
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
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
**If Pregnant or Breast Feeding:**
Consult a health professional before use