FLUSHABLE WIPES- dimethicone gel
SVS, LLC (DBA S2S Global)

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

Dimethicone 3.2%

Purpose

Skin Protectant

Use

provides temporary relief to irritated skin

Warning

For external use only
Do not use on

Large cuts or wounds

severe burns

eyes or near mouth

stop use and call a doctor if

symptoms last for greater than 7 days or reoccur after clearing up

Keep out of reach of children ,seek medical attention if swallowed

Directions

peel back sticker

clean affected area with wipe

dispose of wipe properly

reseal label

INACTIVE INGREDIENT

Aqua
Glycerin
Propylene Glycol
Polyaminopropyl Biguanide
Polysorbate 20
Allantoin
Chlorphenesin
Decyl Glucoside
2-Bromo-2-Nitropropane-1,3-Diol
Sodium Citrate

FLUSHABLE WIPES
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69392-901
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3.2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CHLORPHENESIN (UNII: I670DAL4SZ)
BRONOPOL (UNII: 6PU1E16C9W)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69392-901-01	24 in 1 CARTON	07/29/2017
1		290 g in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/29/2017

Labeler - SVS, LLC (DBA S2S Global) (831375089)