COLD THERAPY- menthol spray

Cold Therapy by

Drug Labeling and Warnings

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]

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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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:a

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

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

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

INSTRUCTIONS FOR USE

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

Principal Display Panel

CryoDerm
PAIN RELIEVING
COLD THERAPY SPRAY
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 Liquid . Greaseless . No-Mess . Non-Staining

16 fl.oz. 504mL

INGREDIENTS AND APPEARANCE

COLD THERAPY 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68678-011
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 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68678-011-32	1008 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 68678-011-16	504 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3	NDC: 68678-011-04	126 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

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)