FLEX-POWER RECOVERY- dimethicone cream

Flex-Power Recovery by

Drug Labeling and Warnings

Flex-Power Recovery by is a Otc medication manufactured, distributed, or labeled by Powerful X. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

dimethicone

INACTIVE INGREDIENT

Water, Beeswax, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Cetyl Alcohol, Cetearyl Alcohol, Betaine, 1,2-Hexanedioln, Stearic Acid, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Polysorbate60, Sorbitan Stearate,Vanillyl Butyl Ether, Arginine, PEG-100 Stearate, Portulaca Oleracea Extract, Xanthan Gum, Glyceryl Stearate, Cetearyl Glucoside, p-Anisic Acid, Glyceryl Caprylate, Tocopheryl Acetate, Acetyl Glucosamine, Dimethyl Sulfone, Carbomer, Lavandula Angustifolia (Lavender) Oil, Centella Asiatica Extract, Cucurbita Pepo (Pumpkin) Fruit Extract, Opuntia Ficus-Indica Stem Extract, Hydrogenated Lecithin, Disodium EDTA, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Lactic Acid, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Cholesterol, Punica Granatum Flower Extract, Althaea Rosea Flower Extract, Prunus Mume Flower Extract, Nelumbo Nucifera Flower Extract, Althaea Rosea Root Extract, Prunus Mume Root Extract, Nelumbo Nucifera Root Extract, Lactobacillus Ferment

PURPOSE

skin protectant

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

apply proper amount to the skin

WARNINGS

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEX-POWER RECOVERY 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70042-5001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 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: 70042-5001-1	100 mL in 1 TUBE; Type 0: Not a Combination Product	12/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/29/2016

Labeler - Powerful X (689515038)

Registrant - Powerful X (689515038)

Establishment
Name	Address	ID/FEI	Business Operations
Powerful X		689515038	manufacture(70042-5001) , label(70042-5001) , pack(70042-5001)