PAIN RELIEVING 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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Pain Relieving Cold Therapy

Active Ingredient

Menthol USP 10.0%

Purpose

Pain Reliever

Uses

Temporarily relieves minor minor aches and pains associated with

Warnings

For external use only

When using this product

Use only as directed

Do not bandage or cover the area being treated

Do not apply ice or heating pad in conjunction with this product

Do not use with any medical device or any other device

Do not combine with any other topical treatments

Avoid contact with eyes or mucous membrane

Do not apply to wounds or damaged skin

Stop use and ask a doctor if:

Conditions worsens or symptoms persist for more than 7 days or clear up and recur

If Pregnant or Breast Feeding

Ask a healthcare professional before use

Keep Out of Reach of Children

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

Directions - Adults and children 2 years of age and older

Massage a liberal amount of gel directly on the skin over the affected area

Children under 2 years of age: Consult a physician

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, Boswella Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone(MSM), Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine

PDP

CryoDerm

Pain Relieving Cold Therapy

Gel

Fast Acting, Penetrating Pain Relief For:

Muscle Strains, Joint Pain, Backachke, Arthritis, Sprained Ligaments & Bruises.

Contains Essential Oils and Natural Extracts

MSM Arnica Boswellia Ilex

Active Ingredient: Menthol

1 Gallon 128 fl. oz 4.2L

gallon

PAIN RELIEVING COLD THERAPY 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68678-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
TROLAMINE (UNII: 9O3K93S3TK)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68678-051-384.2 L 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)

Revised: 5/2022
Document Id: de20f3ae-5d78-fa08-e053-2995a90a615c
Set id: de210c3a-c24e-cefd-e053-2a95a90a93ff
Version: 1
Effective Time: 20220503
 
AHC VENTURES CORP DBA CRYODERM