FDA.reportPublic FDA data

Cryoderm Cold Therapy Spray

Manufacturer
AHC Ventures Corp DBA Cryoderm
Effective date
2025-09-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:12:24

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

Label contents#

Full prescribing information#

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 irritatio develops

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Arnica, Boswella Serrata, Eucalyptus Oil, Ilex Paragariensis Leaf Extract, Dimethyl Sulfone (MSM), Prppermint Oil, Purified Wter, SD Alcohol 39-C

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a healthcare professional before use

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 ointmen

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 10.0%

Uses

INDICATIONS & USAGE SECTION

Temporary relieves minor aches and pains associated with

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

Purpose

OTC - PURPOSE SECTION

Pain Reliever   

Warnings

WARNINGS SECTION

For external use only

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

INSTRUCTIONS FOR USE SECTION

Adults and children 2 years and older:
Spray directly onto 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

Inactive Ingredients

DOSAGE & ADMINISTRATION SECTION

Arnica, Boswella Serrata, Eucalyptus Oil, Ilex Paragariensis Leaf Extract, Dimethyl Sulfone (MSM), Prppermint Oil, Purified Wter, SD Alcohol 39-C

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CryoDerm

Pain Relieving Cold Therapy

Spray

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

16 fl. oz. 504 mL

16 oz spray16 oz spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1371206menthol 1 % Topical SprayPSN5
1371206menthol 10 MG/ML Topical SpraySCD5
1371206menthol 1 % Topical SpraySY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68678-012-042025-09-02C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-012-162025-09-02C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-012-322025-09-02C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-012-042024-01-30C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-012-162024-01-30C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-012-322024-01-30C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-042022-05-04C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-162022-05-04C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-322022-05-04C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-042020-01-31C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-162020-01-31C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-322020-01-31C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-012-04Cold Therapy126 mL in 1 BOTTLE, SPRAYSPRAY1265
68678-012-16Cold Therapy504 mL in 1 BOTTLE, SPRAYSPRAY5045
68678-012-32Cold Therapy1008 mL in 1 BOTTLE, SPRAYSPRAY10085

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68678-01268678-012-32, 68678-012-16, 68678-012-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
EUCALYPTOLRV6J6604TKIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
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 Cryodermdd95c682-8ddf-43e7-a277-2fca6ec744cc2025-09-02WarningsExact identifier
ndc (package): 68678-012-32
ndc (package): 68678-012-16
ndc (package): 68678-012-04
ndc (product): 68678-012
ndc11 (package): 68678001216
ndc11 (package): 68678001232
ndc11 (package): 68678001204
spl id: 3dd5f406-2bb4-a4f9-e063-6294a90a16b2
spl set id: dd95c682-8ddf-43e7-a277-2fca6ec744cc

Reported adverse events (FAERS/openFDA)#

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