HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by IDEAL BEAUTY ALLIANCE SDN. BHD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl Alcohol 62.4% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Warnings

For External Use Only

WHEN USING

When using this product do not us in or near the eyes. If contact occurs, rinse thoroughly with water.

WARNINGS

Flammable. Keep away from fire or flame.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children.

Children must be supervised in use of this product. If swallowed get medical help right away.

Inactive Ingredients

Water, Glycerin, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Propylene Glycol, Aminomethyl Propanol, Fragrance, Tetrasodium EDTA, Benzophenone-4

Directions

Put a small amount in your palm and thoroughly spread on both hands. Rub hands together until dry

Uses

• Hand Sanitizer to help reduce bacteria on the skin=
• Recommended for repeated use
• No washing is needed

Other Information

• Do not store above 110°F (43°C).
• May discolor certain fabrics or surfaces.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78010-062
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62.4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	32.69 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.8 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	2 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.8 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78010-062-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020
2	NDC: 78010-062-08	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020
3	NDC: 78010-062-17	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020
4	NDC: 78010-062-40	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/18/2020

Labeler - IDEAL BEAUTY ALLIANCE SDN. BHD. (659307204)

Registrant - IDEAL BEAUTY ALLIANCE SDN. BHD. (659307204)

Establishment
Name	Address	ID/FEI	Business Operations
IDEAL BEAUTY ALLIANCE SDN. BHD.		659307204	manufacture(78010-062)