FLEXPOWER SUN BLOCK- dimethicone gel

Flexpower Sun Block by

Drug Labeling and Warnings

Flexpower Sun Block 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, butylene glycol, etc.

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

FLEXPOWER SUN BLOCK 
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70042-2001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 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: 70042-2001-1	60 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/11/2015

Labeler - Powerful X (689515038)

Registrant - Powerful X (689515038)

Establishment
Name	Address	ID/FEI	Business Operations
Powerful X		689515038	manufacture(70042-2001)