PremierPro Flushable Wipes with Dimethicone

Manufacturer: HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.
Effective date: 2018-01-09
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 22:54:02

Label at a glance#

ProductPremierPro Flushable Wipes with Dimethicone

Active ingredientDIMETHICONE

Label structure7 sections

Indications and 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.

Dosage and administration

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 maximu...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 3.2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

For external use only.

Avoid contact with the eyes

Stop use

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Do not use:

OTC - DO NOT USE SECTION

• On deep or puncture wounds • Animal bites • Serious burns

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1039149	dimethicone 3.2 % Medicated Pad	PSN	7
1039149	dimethicone 32 MG/ML Medicated Pad	SCD	7
1039149	dimethicone 3.2 % Medicated Pad	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61312-010-01	2020-01-31	C162847	48780-1	9d75b9d0-43c0-f424-e053-dadaa90a57ce	61312-010 PremierPro Flushable Wipes with Dimethicone Personal Cleansing Cloths with Dimethicone, 42 count

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61312-010-01	PremierPro Flushable Wipes with Dimethicone	24 in 1 CASE	SWAB	24		7
61312-010-01	PremierPro Flushable Wipes with Dimethicone	216 g in 1 PACKAGE	SWAB	216		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61312-010	PREMIERPRO FLUSHABLE WIPES WITH DIMETHICONE (DIMETHICONE) SWAB [HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.]	7	Legacy NDC, 2 package rows	20180110_3af8e562-97b4-46c8-a4a6-8105d7d708c2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

PremierPro Flushable Wipes with Dimethicone
DIMETHICONE
WATER
GLYCERIN
PROPYLENE GLYCOL
POLYSORBATE 20
ALLANTOIN
CHLORPHENESIN
DECYL GLUCOSIDE
SODIUM CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61312-010	61312-010-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
ALLANTOIN	344S277G0Z	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
DECYL GLUCOSIDE	Z17H97EA6Y	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
62583244-ebd5-71c8-e053-2a91aa0a54eb			3af8e562-97b4-46c8-a4a6-8105d7d708c2	2018-01-09	Warnings	Exact identifier spl id: 62583244-ebd5-71c8-e053-2a91aa0a54eb spl set id: 3af8e562-97b4-46c8-a4a6-8105d7d708c2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.