Pain Relieving Roll-On
Cryoderm Heat Warming Roll On
799751f3-726a-42de-934e-dbc3cd1cb8b8
HUMAN OTC DRUG LABEL
Sep 2, 2025
AHC VENTURES CORP DBA CRY
DUNS: 131871779
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Menthol, Camphor, Capsaicin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (22)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
INDICATIONS & USAGE SECTION
**Uses**
Temporary relieves minor aches and pains associated with
- sore muscles and joints
- arthritis
- backache
- muscle strains
- sprains
- bruises
CONTRAINDICATIONS SECTION
**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
WARNINGS SECTION
**Warnings:**
**For external use only**
DOSAGE & ADMINISTRATION SECTION
OTC - PURPOSE SECTION
Purpose
Pain Reliever
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
OTC - ACTIVE INGREDIENT SECTION
**Active Ingredient**
Menthol USP 3.85%
Camphor USP 3.85%
Capsaicin USP 0.0355%
INSTRUCTIONS FOR USE SECTION
**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
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
INACTIVE INGREDIENT SECTION
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
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 a doctor if:**
Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritatio develops
OTC - PREGNANCY OR BREAST FEEDING SECTION
**If Pregnant or Breast Feeding:**
Ask a health professional before use