COLD THERAPY- menthol spray 
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 Spray

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 irritatio develops

Inactive Ingredients

Arnica, Boswella Serrata, Eucalyptus Oil, Ilex Paragariensis Leaf Extract, Dimethyl Sulfone (MSM), Prppermint Oil, Purified Wter, SD Alcohol 39-C

If Pregnant or Breast Feeding

Ask a healthcare professional before use

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 ointmen

Active Ingredient

Menthol USP 10.0%

Uses

Temporary relieves minor aches and pains associated with

Purpose

Pain Reliever   

Warnings

For external use only

Keep Out Of Reach Of Children

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

Adults and children 2 years and older:
Spray directly onto 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

Inactive Ingredients

Arnica, Boswella Serrata, Eucalyptus Oil, Ilex Paragariensis Leaf Extract, Dimethyl Sulfone (MSM), Prppermint Oil, Purified Wter, SD Alcohol 39-C

PDP

CryoDerm

Pain Relieving Cold Therapy

Spray

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

16 fl. oz. 504 mL

16 oz spray

COLD THERAPY 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68678-012
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
EUCALYPTOL (UNII: RV6J6604TK) 0.05 mL  in 100 mL
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) 1 mL  in 100 mL
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) 2 mL  in 100 mL
PEPPERMINT OIL (UNII: AV092KU4JH) 0.05   in 100 mL
WATER (UNII: 059QF0KO0R) 33.5   in 100 mL
ALCOHOL (UNII: 3K9958V90M) 51.4 mg  in 100 mL
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68678-012-321008 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2016
2NDC:68678-012-16504 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2016
3NDC:68678-012-04126 mL in 1 BOTTLE, SPRAY; 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: de9b93e3-6468-3c19-e053-2995a90acc90
Set id: dd95c682-8ddf-43e7-a277-2fca6ec744cc
Version: 4
Effective Time: 20220509
 
AHC Ventures Corp DBA Cryoderm