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Cold Therapy by AHC VENTURES CORP DBA CRYODERM

Medically reviewed on Dec 28, 2017

Dosage form: gel
Ingredients: MENTHOL 10g in 100mL
Labeler: AHC VENTURES CORP DBA CRYODERM
NDC Code: 68678-011

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.

Active Ingredient

Menthol USP 10.0%

Purpose

Pain Reliever

Uses

Temporary relieves minor aches and pains associated with

  • sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises

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

If Pregnant or Breast Feeding:

Ask a health 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 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

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

PDP

CryoDerm
PAIN RELIEVING
COLD THERAPY GEL
Vanishing Scent . Natural Soothing Menthol
Essential Oils & Natural Extracts
Paraben Free / Propylene Glycol Free / Aspirin Free
NSAID Free / Silicone Dioxide Free / Gluten Free
Fast, Deep Penetrating Pain Relief for:
Muscle Strains, Joint Pain, Backache, Arthritis,
Sprained Ligaments & Bruises
Pain Relieving Gel . Greaseless . No-Mess . Non-Staining
4 fl.oz. 126mL

COLD THERAPY 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68678-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA1 mL  in 100 mL
BOSWELLIA SERRATA WHOLE1 mL  in 100 mL
EUCALYPTOL0.05 mL  in 100 mL
GLYCERIN5 mL  in 100 mL
ILEX PARAGUARIENSIS LEAF1 mL  in 100 mL
DIMETHYL SULFONE0.03 mL  in 100 mL
PEPPERMINT OIL0.05 mL  in 100 mL
WATER32.906 mL  in 100 mL
ALCOHOL48.4 mL  in 100 mL
TROLAMINE0.5 mL  in 100 mL
(C10-C30)ALKYL METHACRYLATE ESTER0.004 mL  in 100 mL
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68678-011-05126 mL in 1 BOTTLE, DISPENSING
2NDC:68678-011-17504 mL in 1 BOTTLE, DISPENSING
3NDC:68678-011-993 mL in 1 PACKET
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)

 
AHC VENTURES CORP DBA CRYODERM

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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