Your browser does not support JavaScript! ROYAL HAND SANITIZER (ALCOHOL) GEL [GPM INVESTMENTS LLC]
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RxNorm Names

ROYAL HAND SANITIZER (alcohol) gel
[GPM Investments LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient

Ethyl Alcohol 62 percent

Purpose

Antimicrobial

Use

hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

Flammable. Keep away from fire or flame
For external use only.

When using this product

Do not use in eyes.
In case of contact with eyes, rinse with water

Stop use and ask a doctor if

irritation and redness develops and persists.

Keep out of reach of children

if swallowed, get medical help promptly.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store under 105 degrees F

Inactive ingredients

Water, PEG12-Dimethicone, Carbomer, Fragrance. Aloe Barbadersis Leaf Juice, Triethanolamine.

Package label

ROYAL ALOE Hand Sanitizer

CAUTION:EYE IRRITANT! MAY BE HARMFUL IF SWALLOWED.
SEE CAUTION ON BACK PANEL.

2 fl oz 60ml

Made in China

packaging label

ROYAL HAND SANITIZER  
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55439-000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL620 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALOE VERA LEAF 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:55439-000-6060 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/07/2013
Labeler - GPM Investments LLC (132355574)
Registrant - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Kejing Cleaning Products Co., Ltd.526877847manufacture(55439-000)

Revised: 01/2013
Document Id: 674d70e4-8be1-4f0f-bc01-4a41b8e36dde
Set id: 08edae13-e1f2-4fd2-860f-eace27b4b07b
Version: 2
Effective Time: 20130109
 
GPM Investments LLC

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