FDA.reportPublic FDA data

Cold Therapy Menthol Gel

Manufacturer
AHC VENTURES CORP DBA CRYODERM
Effective date
2025-09-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:12:23

Label at a glance#

ProductCold Therapy
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

Temporary relieves minor aches and pains associated with sore muscles and joints arthritis backache muscle strains sprains bruises

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 10.0%

Purpose

OTC - PURPOSE SECTION

Pain Reliever

Uses

INDICATIONS & USAGE SECTION

Temporary relieves minor aches and pains associated with

  • sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises

Warnings:

WARNINGS SECTION

For external use only

When using this product:

OTC - WHEN USING SECTION

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

Stop use and ask doctor if:

OTC - STOP USE SECTION

Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritation develops

If Pregnant or Breast Feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep Out of Reach of Children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion get medical help or contact a Poison Control Center immediately

Directions:

INSTRUCTIONS FOR USE SECTION

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

Other Information

OTHER SAFETY INFORMATION

Store in a cool dry place with lid or cap closed tightly

Flammable: Keep away from excessive heat or open flame

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Acrylates, Arnica, Boswellia Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone, Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

4 oz cold gel4 oz cold gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259249menthol 10 % Topical GelPSN4
259249menthol 0.1 MG/MG Topical GelSCD4
259249menthol 10 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68678-011-052025-09-02C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-172025-09-02C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-992025-09-02C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-052024-01-30C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-172024-01-30C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-992024-01-30C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-052022-05-03C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-172022-05-03C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-992022-05-03C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-052020-01-31C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-172020-01-31C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-992020-01-31C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-011-05Cold Therapy126 mL in 1 BOTTLE, DISPENSINGGEL1264
68678-011-17Cold Therapy504 mL in 1 BOTTLE, DISPENSINGGEL5044
68678-011-99Cold Therapy3 mL in 1 PACKETGEL34

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68678-01168678-011-05, 68678-011-17, 68678-011-99

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
EUCALYPTOLRV6J6604TKIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
TROLAMINE9O3K93S3TKIACT
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERM90334420-5f81-4284-9a57-42e134ce362f2025-09-02WarningsExact identifier
ndc (package): 68678-011-17
ndc (package): 68678-011-99
ndc (package): 68678-011-05
ndc (product): 68678-011
ndc11 (package): 68678001117
ndc11 (package): 68678001199
ndc11 (package): 68678001105
spl id: 3dd632d6-58a1-ab21-e063-6394a90a850c
spl set id: 90334420-5f81-4284-9a57-42e134ce362f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.