PREMIERPRO FLUSHABLE WIPES WITH DIMETHICONE- dimethicone swab 
HANGZHOU GUOGUANG TOURING COMMODITY 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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61312-010 PremierPro Flushable Wipes with Dimethicone
Personal Cleansing Cloths with Dimethicone, 42 count

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.

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:

24pack

PREMIERPRO FLUSHABLE WIPES WITH DIMETHICONE 
dimethicone swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61312-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE32 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61312-010-0124 in 1 CASE07/13/2017
1216 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/13/2017
Labeler - HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. (526890634)
Establishment
NameAddressID/FEIBusiness Operations
HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.526890634manufacture(61312-010)

Revised: 1/2018
Document Id: 62583244-ebd5-71c8-e053-2a91aa0a54eb
Set id: 3af8e562-97b4-46c8-a4a6-8105d7d708c2
Version: 7
Effective Time: 20180109
 
HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.