Royal 70% Alcohol Foam Hand Sanitizer

Royal 70-percent Alcohol Foam Hand Sanitizer by

Drug Labeling and Warnings

Royal 70-percent Alcohol Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Guangzhou Gotdya Fine Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROYAL 70-PERCENT ALCOHOL FOAM HAND SANITIZER- ethyl alcohol liquid 
Guangzhou Gotdya Fine Chemical Co., Ltd.

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 70% Alcohol Foam Hand Sanitizer

Active ingredient

Ethyl Alcohol 70 %

Purpose

Antibacterial

PURPOSE

ANTIBACTERIAL

Uses

• For sanitizing to reduce bacteria on the skin.

Warnings

For external use only

Flammable : Keep away from fire or flame

When using this product

• avoid contact with eyes. In case of eye contact, flush with water

Keep out of reach of children.

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

Directions

• Apply one shot of foaming sanitizer to dry hands
• Rub into skin
• No rinsing required

Inactive ingredients

Water, Isopropyl Alcohol, Propylene Glycol, PEG-12 Dimethicone Crosspolymer, BIS-PEG-12 Dimethicone.

ROYAL 70-PERCENT ALCOHOL FOAM HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76591-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76591-108-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/01/2016

Labeler - Guangzhou Gotdya Fine Chemical Co., Ltd. (551470189)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Gotdya Fine Chemical Co., Ltd.		551470189	manufacture(76591-108)

Revised: 3/2021

Document Id: 435875b4-d993-4344-a24d-5e0c1a445a87

34390-5

Set id: 933a9ef1-8a3b-4fe2-b17e-f6e9cfaaf63e

Version: 1

Effective Time: 20210308