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

Premium Nature Instant hand sanitizer by

Drug Labeling and Warnings

Premium Nature 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]

PREMIUM NATURE 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 65%

Purpose

Antiseptic

Uses

For hand sanitizing to decrease bacteria on skin

Recommended for repeated use

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 eyes with water.

Stop use and ask a doctor if: irritation or redness develops,or if condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions

Squeeze appropriate amount of sanitizer on to hands and rub together until dry.

Direction

Use as needed. For children under 6, use with adult supervision.Not recommended for infants.

Inactive ingredients

ALOE BARBADENSIS LEAF EXTRACT, WATER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TETRAHYDROXYPROPYL ETHYLENEDIAMINE

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

118mL NDC: 74935-010-04

236mL NDC: 74935-010-08

PREMIUM NATURE INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74935-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
EDETOL (UNII: Q4R969U9FR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74935-010-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
2	NDC: 74935-010-08	236 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(74935-010)

Revised: 4/2020

Document Id: a33c3792-8052-3b69-e053-2995a90a10b3

34390-5

Set id: a33c3792-8051-3b69-e053-2995a90a10b3

Version: 1

Effective Time: 20200414

 

Guangzhou Orchard Aromatherapy & Skin Care Co.,Ltd