Pain Relieving Cold Therapy
Pain Relieving Cold Therapy
de210c3a-c24e-cefd-e053-2a95a90a93ff
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, 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
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves minor minor aches and pains associated with
- sore musclkes and joints
- arthritis
- backache
- muscle strains
- sprains
- bruises
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Menthol USP 10.0%
OTC - PURPOSE SECTION
Purpose
Pain Reliever
WARNINGS SECTION
Warnings
For external use only
OTC - WHEN USING SECTION
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
OTC - STOP USE SECTION
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
NURSING MOTHERS SECTION
If Pregnant or Breast Feeding
Ask a healthcare professional before use
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
DOSAGE & ADMINISTRATION SECTION
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
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, Boswella Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone(MSM), Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine