Label: ROYAL HAND SANITIZER - alcohol gel
- NDC Code(s): 55439-000-60
- Packager: GPM Investments LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated January 9, 2013
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- Active ingredient
Ethyl Alcohol 62 percentClose
hand sanitizer to help reduce bacteria on the skin that could cause disease.Close
Flammable. Keep away from fire or flameClose
For external use only.
- When using this product
Do not use in eyes.Close
In case of contact with eyes, rinse with water
- Stop use and ask a doctor if
irritation and redness develops and persists.Close
- Keep out of reach of children
if swallowed, get medical help promptly.Close
Wet hands thoroughly with product and allow to dry without wiping.Close
- Other information
Store under 105 degrees FClose
- Inactive ingredients
Water, PEG12-Dimethicone, Carbomer, Fragrance. Aloe Barbadersis Leaf Juice, Triethanolamine.Close
- 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
- INGREDIENTS AND APPEARANCE
ROYAL HAND SANITIZER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55439-000 Route of Administration TOPICAL 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)