FDA.reportPublic FDA data

PROTEC PAIN RELIEF COLD THERAPY

Manufacturer
AHC VENTURES
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 PAIN RELIEF COLD THERAPY
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: 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

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:

OTC - WHEN USING SECTION

  • 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:

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 accidential 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: 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:

OTHER SAFETY INFORMATION

Store in a 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, Citric Acid, SD Alcohol 39 C, Purified Water

PACKAGE LABEL.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

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
351286menthol 8 % Topical SprayPSN2
351286menthol 80 MG/ML Topical SpraySCD2
351286menthol 8 % Topical SpraySY2

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
68678-065-042020-01-31C16284748780-19d75b9d1-0e61-f424-e053-dadaa90a57ce2adc38b0-f890-4195-81e8-7cd930cc9dff

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-065-04PROTEC PAIN RELIEF COLD THERAPY126 mL in 1 BOTTLE, SPRAYSPRAY1262

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68678-065PROTEC PAIN RELIEF COLD THERAPY (MENTHOL) SPRAY [AHC VENTURES]2Legacy NDC, 1 package rows20160225_2adc38b0-f890-4195-81e8-7cd930cc9dff.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68678-06568678-065-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ALCOHOL3K9958V90MIACT
EUCALYPTUS OIL2R04ONI662IACT
PEPPERMINT OILAV092KU4JHIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
HYALURONIC ACIDS270N0TRQYIACT
ARNICA MONTANAO80TY208ZWIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
YUCCA SCHIDIGERA08A0YG3VICIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
WATER059QF0KO0RIACT
NITRIC OXIDE31C4KY9ESHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
d2185c5f-4fa7-4c92-b545-973cefe9529a2adc38b0-f890-4195-81e8-7cd930cc9dff2016-02-24WarningsExact identifier
spl id: d2185c5f-4fa7-4c92-b545-973cefe9529a
spl set id: 2adc38b0-f890-4195-81e8-7cd930cc9dff

Reported adverse events (FAERS/openFDA)#

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