PROTEC PAIN RELIEF COLD THERAPY- menthol spray 
AHC VENTURES

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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Active Ingredient

Menthol USP 8.0%

Purpose

Pain Reliever

Uses:

Temporary relieves minor aches and pains associated with

Warnings:

For external use only

When using this product:

Stop use and ask doctor if:

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

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

Label

PROTEC PAIN RELIEF COLD THERAPY 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68678-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68678-065-04126 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/24/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/24/2016
Labeler - AHC VENTURES (131871779)
Establishment
NameAddressID/FEIBusiness Operations
AHC VENTURES131871779manufacture(68678-065)

Revised: 2/2016
Document Id: d2185c5f-4fa7-4c92-b545-973cefe9529a
Set id: 2adc38b0-f890-4195-81e8-7cd930cc9dff
Version: 2
Effective Time: 20160224
 
AHC VENTURES