PROTEC ROLL-ON

Manufacturer
ACH VENTURES CORP
Effective date
2016-02-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:45:10

Label at a glance#

ProductPROTEC ROLL-ON
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

Temporary relieves minor aches and pains associated with •sore muscles and joints •arthritis •backache •muscle strains •sprains •bruises

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 8.0%

Purpose

OTC - PURPOSE SECTION

Pain Reliever

Uses

INDICATIONS & USAGE SECTION

Temporary relieves minor aches and pains associated with
•sore muscles and joints
•arthritis
•backache
•muscle strains
•sprains
•bruises

Warnings:

WARNINGS SECTION

For external use only

When using this product: Use only as directed

OTC - WHEN USING SECTION

•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:

OTC - STOP USE SECTION

•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:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INSTRUCTIONS FOR USE SECTION

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

OTHER SAFETY INFORMATION

Store in cool dry place with lid or cap closed tightly

Flammable: Keep away from excessive heat or open flame

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283257menthol 8 % Topical GelPSN2
283257menthol 0.08 MG/MG Topical GelSCD2
283257menthol 8 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
46e64ad7-7dca-4816-a2a4-8cdff2136105Product name220240828

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68678-067-042020-01-31C16284748780-19d75b9d0-311b-f424-e053-dadaa90a57cede81646b-748e-4cfd-93f1-a83abc91da42

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-067-04PROTEC ROLL-ON95 mL in 1 BOTTLE, DISPENSINGGEL952

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68678-067PROTEC ROLL-ON (MENTHOL) GEL [ACH VENTURES CORP]2Legacy NDC, 1 package rows20160225_de81646b-748e-4cfd-93f1-a83abc91da42.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68678-06768678-067-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d617965-6c3a-431f-b4f9-43df13744f95de81646b-748e-4cfd-93f1-a83abc91da422016-02-24WarningsExact identifier
spl id: 0d617965-6c3a-431f-b4f9-43df13744f95
spl set id: de81646b-748e-4cfd-93f1-a83abc91da42

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.