CRYO10 TOPICAL ANALGESIC- menthol gel 
Element 26 LLC

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Cryo10 Topical Analgesic

Drug Facts

Active Ingredient

Menthol 10.0%

Purpose

Topical Analgesic

Uses

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

Warnings

Avoid contact with eyes. For external use only.

Flammable: Keep away from fire or flame.

When using this product

• 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

• 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,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• 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

Inactive Ingredients

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:

label

CRYO10 TOPICAL ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83549-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83549-000-0188 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/26/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/26/2023
Labeler - Element 26 LLC (099970978)

Revised: 10/2023
Document Id: 08853630-67a7-fee9-e063-6394a90a4c1e
Set id: ff1d2140-9302-918c-e053-6394a90acb9a
Version: 2
Effective Time: 20231025
 
Element 26 LLC