ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by JOUAN CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Uses

• hand sanitizer to reduce bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

Flammable. Keep away from fire/flame

For external use only

Do not use

• on children under 2 months of age
• on open skin wounds

When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop
• 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

• Apply sufficient amount and spread evenly over entire hands. Rub repeatly until dry without wiping.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• store between 15-30°C (59-86° F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

glycerin, aloe vera gel, vitamin E, lemon oil, water

Questions?

+1-302-509-8362

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM EST

SPL UNCLASSIFIED SECTION

Sanitizing Moisturizing

Effective Disinfection

Vitamin E, Aloe Vera, Moisturizing, Nourishing

SAFE, NON-TOXIC, CONVENIENT, EFFECTIVE

Manufactured by: JOUAN CO LTD, 4F., No 10, Ln. 218, Sec. 2, Zhongxing Rd., Xindian Dist., New Taipei City, Taiwan (R.O.C), 23146

Product of Taiwan

Waived for general skincare product.

Shelf life: 5 years

This product is manufactured by Jouan Co., Ltd.
certified by the international GMP ISO22716

Packaging

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79302-302
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
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
LEMON OIL (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79302-302-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
2	NDC: 79302-302-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
3	NDC: 79302-302-03	65 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
4	NDC: 79302-302-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
5	NDC: 79302-302-05	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
6	NDC: 79302-302-06	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
7	NDC: 79302-302-07	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
8	NDC: 79302-302-08	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
9	NDC: 79302-302-09	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
10	NDC: 79302-302-10	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/30/2020

Labeler - JOUAN CO., LTD. (656021851)

Establishment
Name	Address	ID/FEI	Business Operations
JOUAN CO., LTD.		656021851	manufacture(79302-302)