RoyalCare Sanitizing Wipes by Royal Beauty Group, Llc

RoyalCare Sanitizing Wipes by

Drug Labeling and Warnings

RoyalCare Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by Royal Beauty Group, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROYALCARE SANITIZING WIPES- isopropyl alcohol cloth 
Royal Beauty Group, Llc

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.

----------

Active Ingredient

Isopropyl Alcohol 75% v/v.

Purpose

Antiseptic

Use

Alcohol antiseptic wipe helps reduce harmful bacteria and germs that potentially can cause disease.

Warnings

Flammable, keep away from heat and flame. For external use only.

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

To dispense, lift cover, open the bag, pull center sheet from roll, twist to a point, feed through dispenser hole in cover. Keep cap closed to prevent moisture loss. Use entire wipe to thoroughly wipe hands, surfaces. To sanitize, use multiple wipes. Discard after single use.

Other information

• Store at room temperature15° C~30° C (59° F~86°)
• Avoid freezing and excessive heat above 40° C (104° F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Net contents

800 wipes; dimension: 14cm X 20cm (5.5” X 8”) spunlace nonwoven fabric; net weight 4.2kg (9.2lbs)

Package Label - Principal Display Panel

ROYALCARE SANITIZING WIPES 
isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80759-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80759-801-10	800 in 1 PACKAGE	10/05/2020	10/30/2021
1		3.2 mL 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 not final	part333A	10/05/2020	10/30/2021

Labeler - Royal Beauty Group, Llc (117547219)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Beauty Group, Llc		117547219	manufacture(80759-801)

Revised: 12/2022

Document Id: e6976cf9-952c-452e-881b-8784f7983f7c

34390-5

Set id: e14278b7-b005-45c8-9e7e-b1479bf4cd7a

Version: 2

Effective Time: 20221208