INSTANT HAND SANITZER gel

INSTANT HAND SANITZER by

Drug Labeling and Warnings

INSTANT HAND SANITZER by is a Otc medication manufactured, distributed, or labeled by Jinhua City Wellmae Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl alcohol 70% v/v

Purpose

antimicrobial

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not availablee.
Recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

Do not use children less than 2 months of age on open skin wounds.

WHEN USING

When using this product keep out of eyes, ears, and mouth.
In case of contact with eyes, rinse eyes thoroughly with water and seek medical attention immediately.

STOP USE

Stop use or consult a doctor If irritation or rash occurs.
These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a poison central right away

Directions

• Place enough product on hands to cover all surfaces.
• Rub hands together until dry.
• Use as needed no need to rinse with water.
• For children under 6 years of age, use only under adult supervisione.
• Not recommender for infants.

Other information

Store between 15-30°C(59-86°F)
Avoid freezing and excessive heat above 40°C(104 °F)

Inactive ingredients

Water, carbomer, triethanolamine

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITZER 
instant hand sanitzer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75427-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75427-005-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 75427-005-02	40 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 75427-005-04	55 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 75427-005-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 75427-005-05	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 75427-005-06	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 75427-005-07	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 75427-005-08	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC: 75427-005-09	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC: 75427-005-10	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
11	NDC: 75427-005-11	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
12	NDC: 75427-005-12	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
13	NDC: 75427-005-13	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
14	NDC: 75427-005-14	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Jinhua City Wellmae Cosmetics Co., Ltd. (543459963)

Establishment
Name	Address	ID/FEI	Business Operations
Jinhua City Wellmae Cosmetics Co., Ltd.		543459963	manufacture(75427-005) , label(75427-005)