PREMIERPRO FLUSHABLE WIPES WITH DIMETHICONE- dimethicone swab

PremierPro Flushable Wipes with Dimethicone by

Drug Labeling and Warnings

PremierPro Flushable Wipes with Dimethicone by is a Otc medication manufactured, distributed, or labeled by HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Dimethicone  3.2%

Purpose

Skin Protectant

Uses:

Helps treat and prevent diaper rash. Protects chafed skin associated with diaper rash and helps protect from wetness. Temporarily protects and helps relieve chapped or cracked skin.

Warnings:

For external use only.

• Avoid contact with the eyes​

Stop use

and contact a physician if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Do not use:

On deep or puncture wounds Animal bites Serious burns

Directions:

Pull back label and remove wipes

Thoroughly cleanse soiled area, using one wipe at a time

Use as often as necessary

Dispose of cloths in a waste receptacle

Do not flush

Heating Instructions:

Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed:

in a single warming session at temperatures not exceeding 52°C (125°F) and

for a maximum of 4 days. Discard wipes that have been:

Exposed to warming temperatures exceeding 52C (125F); or

Stored longer than 4 days within the warmer; or

Been warmed, allowed to cool, and then re-warmed.

Other Information:

When not in a warmer, store between 15-30˚C (59-86˚F)

Inactive Ingredients:

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

Package Labeling:

INGREDIENTS AND APPEARANCE

PREMIERPRO FLUSHABLE WIPES WITH DIMETHICONE 
dimethicone swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61312-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	32 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61312-010-01	24 in 1 CASE	07/13/2017
1		216 g in 1 PACKAGE; 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	07/13/2017

Labeler - HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. (526890634)

Establishment
Name	Address	ID/FEI	Business Operations
HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.		526890634	manufacture(61312-010)