PAIN RELIEVING COLD THERAPY- menthol gel

Pain Relieving Cold Therapy by

Drug Labeling and Warnings

Pain Relieving Cold Therapy by is a Otc medication manufactured, distributed, or labeled by AHC VENTURES CORP DBA CRYODERM. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol USP 10.0%

Purpose

Pain Reliever

Uses

Temporarily relieves minor minor aches and pains associated with

• sore musclkes 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 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

• Redness if present or irritation develops

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

• 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, 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

INGREDIENTS AND APPEARANCE

PAIN RELIEVING COLD THERAPY 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68678-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 L

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68678-051-38	4.2 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2016

Labeler - AHC VENTURES CORP DBA CRYODERM (131871779)