FDA.reportPublic FDA data

Pain Relieving Cold Therapy

Manufacturer
AHC VENTURES CORP DBA CRYODERM
Effective date
2025-09-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:12:24

Label at a glance#

ProductPain Relieving Cold Therapy
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

Temporarily relieves minor minor aches and pains associated with sore musclkes and joints arthritis backache muscle strains sprains bruises

Dosage and administration

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

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

Temporarily relieves minor minor aches and pains associated with

  • sore musclkes 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 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

Stop use and ask a doctor if:

OTC - STOP USE SECTION

Conditions worsens or symptoms persist for more than 7 days or clear up and recur

  • Redness if present or irritation develops

If Pregnant or Breast Feeding

NURSING MOTHERS SECTION

Ask a healthcare 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 - Adults and children 2 years of age and older

DOSAGE & ADMINISTRATION SECTION

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 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, Boswella Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone(MSM), 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, 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

gallongallon

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68678-051-382025-09-02C16284748780-11030e365-6ad6-111a-e063-dadaa90a10e2Pain Relieving Cold Therapy
68678-051-382024-01-30C16284748780-11030e365-6ad6-111a-e063-dadaa90a10e2Pain Relieving Cold Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-051-38Pain Relieving Cold Therapy4.2 L in 1 BOTTLE, DISPENSINGGEL4.22

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
68678-05168678-051-38

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
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
PEPPERMINT OILAV092KU4JHIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
EUCALYPTUS OIL2R04ONI662IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
TROLAMINE9O3K93S3TKIACT
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT

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
Pain Relieving Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERMde210c3a-c24e-cefd-e053-2a95a90a93ff2025-09-02WarningsExact identifier
ndc (package): 68678-051-38
ndc (product): 68678-051
ndc11 (package): 68678005138
spl id: 3dd5fbd3-2a69-9d53-e063-6294a90a40bb
spl set id: de210c3a-c24e-cefd-e053-2a95a90a93ff

Reported adverse events (FAERS/openFDA)#

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