PROTEC PAIN RELIEF COLD THERAPY- menthol spray

PROTEC PAIN RELIEF COLD THERAPY by

Drug Labeling and Warnings

PROTEC PAIN RELIEF COLD THERAPY by is a Otc medication manufactured, distributed, or labeled by AHC VENTURES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol USP 8.0%

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 pd or device
• Avoid contact with eyes and mucous membranes
• Do not apply to open wounds or damaged skin
• Do not use with other ointments, creams, sprays, 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 accidential ingestion get medical help or contact a Poison Control Center immediately

Directions:

Adults and children 2 years of age and older: Spray directly onto affected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more the 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

Ilex Paraguariensis Leaf Extract, Arnica, Boswellia Serrata, Eucalyptus Oil, Peppermint Oil, Hyaluronic Acid, Yucca Extract, Nitric Oxide, Dimethyl Sulfone, Citric Acid, SD Alcohol 39 C, Purified Water

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

PRO-TEC ATHLETICS
PAIN RELIEF
ALL NATURAL SPRAY
RECOVERY COLD THERAPY
Fast Acting, Deep Penetrating Pain Relief from: Muscle Strains, Joint Pain, Tendinitis, Arthritis, Sprained Ligaments & Bruises
4 fl.oz./126 mL

INGREDIENTS AND APPEARANCE

PROTEC PAIN RELIEF COLD THERAPY 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68678-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	51.079 mL  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662)	.05 mL  in 100 mL
PEPPERMINT OIL (UNII: AV092KU4JH)	.05 mL  in 100 mL
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)	5.0 mL  in 100 mL
HYALURONIC ACID (UNII: S270N0TRQY)	.001 mL  in 100 mL
ARNICA MONTANA (UNII: O80TY208ZW)	1.00 mL  in 100 mL
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)	1.00 mL  in 100 mL
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)	.1 mL  in 100 mL
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)	3.0 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	30.699 mL  in 100 mL
NITRIC OXIDE (UNII: 31C4KY9ESH)	.001 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	.001 mL  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: 68678-065-04	126 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/24/2016

Labeler - AHC VENTURES (131871779)

Establishment
Name	Address	ID/FEI	Business Operations
AHC VENTURES		131871779	manufacture(68678-065)