COLD THERAPY- menthol gel 
AHC VENTURES CORP DBA CRYODERM

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Cryoderm Cold Therapy Roll On

Uses

Temporary relieves minor aches and pains associated with

Active Ingredient

Menthol USP 10.0%

Purpose

Pain Reliever

Directions

Adults and children 2 years and older: 

Apply directly onto afected 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

Warnings

For external use only

When using this product:

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 doctor if:

Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritation develops

Keep Out of Reach of Children

In case of accidental ingestion get medical help or contact a Poison Control Center immediately

Other Information:

Store in a cool dry place with lid or cap closed tightly
Flammable: Keep away from excessive heat or open flame

Inactive Ingredients:

Acrylates, Arnica, Boswellia Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone, Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine

If Pregnant or Breast Feeding:

Consult a health professional before use

PDP

CryoDerm

Pain Relieving Cold Therapy

Roll-on

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

3 fl. oz. 95 mL

Roll on 3 oz

COLD THERAPY 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68678-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) 1 mL  in 100 mL
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ) 1 mL  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) 0.05 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 5 mL  in 100 mL
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) 1 mL  in 100 mL
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) 0.03 mL  in 100 mL
PEPPERMINT OIL (UNII: AV092KU4JH) 0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 32.906 mL  in 100 mL
ALCOHOL (UNII: 3K9958V90M) 48.45 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.5 mL  in 100 mL
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) 0.004 mL  in 100 mL
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68678-013-9095 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2016
Labeler - AHC VENTURES CORP DBA CRYODERM (131871779)
Establishment
NameAddressID/FEIBusiness Operations
Vege Labs LLC.117878620manufacture(68678-013)

Revised: 4/2022
Document Id: dd08d57a-e9b0-3146-e053-2995a90ae940
Set id: 52fff03e-eba2-4604-a71c-2522468f627b
Version: 3
Effective Time: 20220419
 
AHC VENTURES CORP DBA CRYODERM