FDA.reportPublic FDA data

Pain Relieving Roll-On

Manufacturer
AHC VENTURES CORP DBA CRY
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#

ProductPain Relieving Roll-On
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC), CAPSAICIN
Label structure13 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 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

Label contents#

Full prescribing information#

Warnings:

WARNINGS SECTION

For external use only

Purpose

OTC - PURPOSE SECTION

Pain Reliever

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

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 3.85%

Camphor USP 3.85%

Capsaicin USP 0.0355%

Directions

INSTRUCTIONS FOR USE SECTION

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

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Uses

INDICATIONS & USAGE SECTION

Temporary relieves minor aches and pains associated with

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

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 a 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

If Pregnant or Breast Feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

This product contains Capsaicin

CONTRAINDICATIONS SECTION

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

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Cryoderm Heat Roll onCryoderm Heat Roll on

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68678-040-902025-09-02C16284748780-19d75b9d0-8101-f424-e053-dadaa90a57ceCryoderm Heat Warming Roll On
68678-040-902024-01-30C16284748780-19d75b9d0-8101-f424-e053-dadaa90a57ceCryoderm Heat Warming Roll On
68678-040-902022-04-21C16284748780-19d75b9d0-8101-f424-e053-dadaa90a57ceCryoderm Heat Warming Roll On
68678-040-902020-01-31C16284748780-19d75b9d0-8101-f424-e053-dadaa90a57ceCryoderm Heat Warming Roll On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-040-90Pain Relieving Roll-On84 mL in 1 BOTTLE, DISPENSINGLOTION844

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68678-04068678-040-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANAO80TY208ZWIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOMER 9404Q93RCW27EIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CITRUS AURANTIUM FRUITDQD16J2B5OIACT
GRAPEFRUITO82C39RR8CIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ROSA CANINA FLOWER81MCR2UQ6QIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
TROLAMINE9O3K93S3TKIACT
YUCCA SCHIDIGERA08A0YG3VICIACT
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
CAPSAICINS07O44R1ZMACTIB

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 Roll-OnMENTHOL, CAMPHOR, CAPSAICINAHC VENTURES CORP DBA CRY799751f3-726a-42de-934e-dbc3cd1cb8b82025-09-02WarningsExact identifier
ndc (package): 68678-040-90
ndc (product): 68678-040
ndc11 (package): 68678004090
spl id: 3dd5fc5a-32c4-78bf-e063-6394a90af02a
spl set id: 799751f3-726a-42de-934e-dbc3cd1cb8b8

Reported adverse events (FAERS/openFDA)#

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