Cryo10 Topical Analgesic

Manufacturer: Element 26 LLC
Effective date: 2023-10-25
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:57:37

Label at a glance#

ProductCryo10 Topical Analgesic

Active ingredientMENTHOL

Label structure7 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Dosage and administration

• roll directly onto affected area without the need to rub, massage or bandage • repeat if necessary, but do not apply more than 4 times daily. Adults and children over 12 years: ask a doctor. Children 12 years of younger:

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Warnings

WARNINGS SECTION

Avoid contact with eyes. For external use only.

Flammable: Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

• use only as directed • do not bandage tightly or use a heating pad • do not apply to wounds or damaged skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days redness is present • excessive irritation of the skin 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

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• roll directly onto affected area without the need to rub, massage or bandage • repeat if necessary, but do not apply more than 4 times daily. Adults and children over 12 years:

ask a doctor. Children 12 years of younger:

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerine, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, triethanolamine, water (USP).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
259249	menthol 10 % Topical Gel	PSN	2
259249	menthol 0.1 MG/MG Topical Gel	SCD	2
259249	menthol 10 % Topical Gel	SY	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83549-000-01	Cryo10 Topical Analgesic	88 mL in 1 BOTTLE, WITH APPLICATOR	GEL	88		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83549-000	CRYO10 TOPICAL ANALGESIC (MENTHOL) GEL [ELEMENT 26 LLC]	2	Current NDC, 1 package rows	20231025_ff1d2140-9302-918c-e053-6394a90acb9a.zip

Products#

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

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

Cryo10 Topical Analgesic
MENTHOL
INDIAN FRANKINCENSE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
DIMETHYL SULFONE
EUCALYPTUS OIL
GLUCOSAMINE SULFATE
GLYCERIN
PEG-8 DIMETHICONE
PENTYLENE GLYCOL
PEPPERMINT OIL
TROLAMINE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
83549-000	83549-000-01

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
Name	UNII	Kind
INDIAN FRANKINCENSE	4PW41QCO2M	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
DIMETHYL SULFONE	9H4PO4Z4FT	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
GLUCOSAMINE SULFATE	1FW7WLR731	IACT
GLYCERIN	PDC6A3C0OX	IACT
PEG-8 DIMETHICONE	GIA7T764OD	IACT
PENTYLENE GLYCOL	50C1307PZG	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	IACT
MENTHOL	L7T10EIP3A	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cryo10 Topical Analgesic	MENTHOL	Element 26 LLC	ff1d2140-9302-918c-e053-6394a90acb9a	2023-10-25	Warnings	Exact identifier ndc (package): 83549-000-01 ndc (product): 83549-000 ndc11 (package): 83549000001 spl id: 08853630-67a7-fee9-e063-6394a90a4c1e spl set id: ff1d2140-9302-918c-e053-6394a90acb9a

Reported adverse events (FAERS/openFDA)#

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