Instant hand sanitizer by Guangzhou Orchard Aromatherapy & Skin Care Co.,Ltd

Instant hand sanitizer by

Drug Labeling and Warnings

Instant hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Guangzhou Orchard Aromatherapy & Skin Care Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INSTANT HAND SANITIZER- alcohol gel 
Guangzhou Orchard Aromatherapy & Skin Care 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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ACTIVE INGREDIENT

Ethyl Alcohol 75% Purpose: Antiseptic

PURPOSE

Antiseptic

USES

For hand sanitizing to decrease bacteria on skin.

WARNINGS

Flammable. Keep away fire or flame.

For external use only. Keep out of eyes. If eye contact occured, flush immediately with water and call a doctor. Stop use and ask a doctor if irritation develops.

KEEP OUT OF REACH OF CHILDREN

Call a doctor or Poison Center if swallowed.

Apply a pea sized amount onto your hand, and rub throughly until dry.

Use as needed. For children under 6, use with adult supervision.

INACTIVE INGREDIENTS

WATER,ALOE BARBADENSIS LEAF EXTRACT,CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT,ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,TETRAHYDROXYPROPYL ETHYLENEDIAMINE,GLYCERIN,SODIUM HYALURONATE

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

250mL NDC: 74935-001-02

500MLNDC: 74935-001-01

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74935-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETOL (UNII: Q4R969U9FR)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
CHAMOMILE (UNII: FGL3685T2X)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74935-001-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
2	NDC: 74935-001-02	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020

Labeler - Guangzhou Orchard Aromatherapy & Skin Care Co.,Ltd (542355899)

Registrant - Guangzhou Orchard Aromatherapy & Skin Care Co.,Ltd (542355899)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Orchard Aromatherapy & Skin Care Co.,Ltd		542355899	manufacture(74935-001)

Revised: 4/2020

Document Id: a34fdb83-563c-b39d-e053-2a95a90a9fe1

34390-5

Set id: a329253d-f145-e125-e053-2995a90aea71

Version: 2

Effective Time: 20200415

 

Guangzhou Orchard Aromatherapy & Skin Care Co.,Ltd