Oppeal. Hosmall Hand Sanitizer

Oppeal Hosmall Hand Sanitizer by

Drug Labeling and Warnings

Oppeal Hosmall Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Jiangsu Oppeal Daily Cosmetics Corp. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OPPEAL HOSMALL HAND SANITIZER- alcohol gel 
Jiangsu Oppeal Daily Cosmetics Corp. 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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Oppeal. Hosmall Hand Sanitizer

DRUG FACTS

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

USES

For hand sanitizing to decrease bacteria on the skin.  Recommended for repeated use.

WARNING

Flammable. Keep away from fire or flame. For external use only. Avoid contact with broken skin.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thorougly with water.

Stop use and ask a doctor 

if irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help.

DIRECTIONS

Not recommended for infants. Wet hands thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product

OTHER INFORMATION

Do not store above 30°C.

May discolor some fabrics.

INACTIVE INGREDIENTS

Aqua(Water), Glycerin, Acrylates/C-10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe Barbadensis Leaf Extract, Parfum (Fragrance).

Package Labeling

Package Labeling:30ml

Package Labeling:60ml(Tube)

Package Labeling:60ml 

Package Labeling:236ml

Package Labeling:500ml

OPPEAL HOSMALL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77828-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77828-003-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2020	12/31/2021
2	NDC: 77828-003-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2020	12/31/2021
3	NDC: 77828-003-04	60 mL in 1 TUBE; Type 0: Not a Combination Product	05/30/2020	12/31/2021
4	NDC: 77828-003-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2020	12/31/2021
5	NDC: 77828-003-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2020	12/31/2021
6	NDC: 77828-003-17	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/30/2020	12/31/2021

Labeler - Jiangsu Oppeal Daily Cosmetics Corp. Ltd. (544096556)

Revised: 1/2022

Document Id: d4aea7fb-5a79-e493-e053-2a95a90a228a

34390-5

Set id: aa8047b7-1e5a-3fca-e053-2a95a90a067c

Version: 4

Effective Time: 20220103

 

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