ROYAL HAND SANITIZER  - alcohol gel 
GPM Investments 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.

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Royal Hand Sanitizer

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 Type HUMAN OTC DRUG Item Code (Source) NDC:55439-000
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 620 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55439-000-60 60 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/07/2013
Labeler - GPM Investments LLC (132355574)
Registrant - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
Establishment
Name Address ID/FEI Business Operations
Shanghai Kejing Cleaning Products Co., Ltd. 526877847 manufacture(55439-000)

Revised: 1/2013
Document Id: 674d70e4-8be1-4f0f-bc01-4a41b8e36dde
Set id: 08edae13-e1f2-4fd2-860f-eace27b4b07b
Version: 2
Effective Time: 20130109
 
GPM Investments LLC