SKIN PROTECTANT FLUSHABLE WIPES- dimethicone liquid
Yinjing Medical Technology (Shanghai) 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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Skin Protectant Flushable Wipes

Active Ingredient

Dimethicone 3.2%

Purpose

Skin Protectant

Use

Temporarily protects and helps relieve chapped or cracked skin

Warnings

For external use only

When using this product do not get into eyes.

Stop use and ask a doctor if

condition worsens
symptoms last more than 7 days to clear up and occur again within a few days
irritation or redness develops

Do not use on

deep or puncture wounds
animal bites
serious burns

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

Open package as designated
Remove cloth and apply to the soiled area
Apply as needed
Dispose of cloth in waste receptacle or flush in toilet

Other Information

Store at room temperature

Inactive Ingredients

WATER, SODIUM COCO PG-DIMONIUM CHLORIDE PHOSPHATE, LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, POLYSORBATE-20, DISODIUM EDTA, CETEARYL ISONONANOATE, CETEARETH-20, CETEARYL ALCOHOL, GLYCERYL STEARATE, CETEARETH-12, CETYL PALMITATE, GLYCERIN, SODIUM BENZOATE, BENZALKONIUM CHLORIDE, PHENOXYETHANOL, ALOE VERA LEAF JUICE, CITRIC ACID

Skin Protectant Flushable Wipes 24 Wipes (44019-004-00)

Skin Protectant Flushable Wipes

SKIN PROTECTANT FLUSHABLE WIPES
dimethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44019-004
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
WATER (UNII: 059QF0KO0R)
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETEARETH-12 (UNII: 7V4MR24V5P)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:44019-004-00	24 in 1 BAG	08/03/2016
1		12.33 g in 1 PATCH; 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	08/03/2016

Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)

Registrant - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)