HEALFLEX RECOVERY- dimethicone cream 
Ace B&C Co.,Ltd

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

Active ingredients: Dimethicone 1.6%

INACTIVE INGREDIENT

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

Purpose: Skin Protectant

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

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

Directions

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 carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

HEALFLEX RECOVERY 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72504-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72504-010-021 in 1 CARTON08/01/2018
1NDC:72504-010-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:72504-010-041 in 1 CARTON08/01/2018
2NDC:72504-010-03150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2018
Labeler - Ace B&C Co.,Ltd (694634808)
Registrant - Ace B&C Co.,Ltd (694634808)
Establishment
NameAddressID/FEIBusiness Operations
NEO-MEDICAL CO.,LTD689755531manufacture(72504-010)

Revised: 8/2018
Document Id: d069696f-2f51-41b5-9651-ca22b3a935ed
Set id: eb99850e-683d-482b-a603-b3a6c554e145
Version: 1
Effective Time: 20180817
 
Ace B&C Co.,Ltd