HEALFLEX RECOVERY

Manufacturer
Ace B&C Co.,Ltd | NEO-MEDICAL CO.,LTD
Effective date
2018-08-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:38

Label at a glance#

ProductHEALFLEX RECOVERY
Active ingredientDimethicone
Label structure9 sections

Indications and uses

Uses: Help the warm-up massage before exercise and the relaxation massage after exercise.

Dosage and administration

Directions: - Before or after exercise and after taking a shower, apply on the shoulders, the neck, the waist, the knees, the calves, and the ankles as if massaging them. - A proper amount for each usage is around 1g. (Almost one knuckle of the small finger) - If sense of heating is not enough after application, then gradually use more.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Dimethicone 1.6%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Water, Butylene Glycol Dicaprylate/Dicaprate, Beeswax, Cetearyl Alcohol, Butylene Glycol, 1,2-Hexanediol, Cetyl Alcohol, Betaine, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Propolis Wax, Caviar Extract, Centella Asiatica Extract, Asiaticoside, Asiatic Acid, Madecassic Acid, Dimethyl Sulfone, Acetyl Glucosamine, Palmitic Acid, Polysorbate 60, Sorbitan Stearate, Vanillyl Butyl Ether, Stearic Acid, Arginine, Citrus Limon (Lemon) Fruit Oil, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Cetearyl Glucoside, Carbomer, Xanthan Gum, Caprylyl Glycol, Disodium EDTA, Alcohol, Polysorbate 80, Lactic acid

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings:

- For external use only

- Use only as directed

- WASH HANDS THOROUGHLY AFTER USE.

- Avoid contact with eyes and sensitive areas.

- DO NOT apply on any scars or irritated areas

- Discontinue use if signs of irritation or rashes appear. If symptoms persist, consult your doctor.

- KEEP OUT OF REACH OF CHILDREN

- Keep the product away from places with high temperature, low temperature, and direct sunlight

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

Uses:

Help the warm-up massage before exercise and the relaxation massage after exercise.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

- Before or after exercise and after taking a shower, apply on the shoulders, the neck, the waist, the knees, the calves, and the ankles as if massaging them.

- A proper amount for each usage is around 1g. (Almost one knuckle of the small finger)

- If sense of heating is not enough after application, then gradually use more.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307862dimethicone 1.6 % Topical CreamPSN1
1307862dimethicone 16 MG/ML Topical CreamSCD1
1307862dimethicone 1.6 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72504-010-022020-01-31C16284748780-19d75b9d0-bad9-f424-e053-dadaa90a57ceeb99850e-683d-482b-a603-b3a6c554e145
72504-010-042020-01-31C16284748780-19d75b9d0-bad9-f424-e053-dadaa90a57ceeb99850e-683d-482b-a603-b3a6c554e145

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72504-010-01HEALFLEX RECOVERY30 mL in 1 CONTAINERCREAM301
72504-010-02HEALFLEX RECOVERY1 in 1 CARTONCREAM11
72504-010-03HEALFLEX RECOVERY150 mL in 1 CONTAINERCREAM1501
72504-010-04HEALFLEX RECOVERY1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72504-010HEALFLEX RECOVERY (DIMETHICONE) CREAM [ACE B&C CO.,LTD]1Legacy NDC, 4 package rows20180817_eb99850e-683d-482b-a603-b3a6c554e145.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72504-01072504-010-01, 72504-010-02, 72504-010-03, 72504-010-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

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
d069696f-2f51-41b5-9651-ca22b3a935edeb99850e-683d-482b-a603-b3a6c554e1452018-08-17WarningsExact identifier
spl id: d069696f-2f51-41b5-9651-ca22b3a935ed
spl set id: eb99850e-683d-482b-a603-b3a6c554e145

Reported adverse events (FAERS/openFDA)#

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