HEALFLEX RECOVERY- dimethicone cream

HEALFLEX RECOVERY by

Drug Labeling and Warnings

HEALFLEX RECOVERY by is a Otc medication manufactured, distributed, or labeled by Ace B&C Co.,Ltd, NEO-MEDICAL CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALFLEX RECOVERY 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72504-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	1.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72504-010-02	1 in 1 CARTON	08/01/2018
1	NDC: 72504-010-01	30 mL in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 72504-010-04	1 in 1 CARTON	08/01/2018
2	NDC: 72504-010-03	150 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/01/2018

Labeler - Ace B&C Co.,Ltd (694634808)

Registrant - Ace B&C Co.,Ltd (694634808)

Establishment
Name	Address	ID/FEI	Business Operations
NEO-MEDICAL CO.,LTD		689755531	manufacture(72504-010)