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PROTEC ROLL-ON

Dosage form: gel
Ingredients: MENTHOL 8g in 100mL
Labeler: ACH VENTURES CORP
NDC Code: 68678-067

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 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 accidental ingestion get medical help or contact a Poison Control Center Immediately

Directions

Adults and children 2 years of age and older: Roll 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 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, SD Alcohol 39 C, Purified Water, Glycerin, Acrylates, Triethanolamine

PRO.TEC ATHLETICS
PAIN RELIEF
ALL NATURAL ROLL ON
RECOVERY COLD THERAPY
Fast Acting, Deep Penetrating Pain Relief from: Muscle Strains, Joint Pain, Tendinitis, Arthritis, Sprained Ligaments & Bruises
3 fl.oz./95 mL

PROTEC ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68678-067
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL50 mL  in 100 mL
WATER26.99 mL  in 100 mL
ILEX PARAGUARIENSIS LEAF5 mL  in 100 mL
DIMETHYL SULFONE3 mL  in 100 mL
GLYCERIN3 mL  in 100 mL
BOSWELLIA SERRATA WHOLE1 mL  in 100 mL
ARNICA MONTANA1 mL  in 100 mL
(C10-C30)ALKYL METHACRYLATE ESTER.40 mL  in 100 mL
TROLAMINE.40 mL  in 100 mL
YUCCA SCHIDIGERA.10 mL  in 100 mL
PEPPERMINT OIL.05 mL  in 100 mL
EUCALYPTUS OIL.05 mL  in 100 mL
NITRIC OXIDE.001 mL  in 100 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68678-067-0495 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/19/2016
Labeler - ACH VENTURES CORP (131871779)
Establishment
NameAddressID/FEIOperations
ACH VENTURES CORP131871779manufacture(68678-067)

 
ACH VENTURES CORP

Medically reviewed on Feb 26, 2018

Further information

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

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