INSTANT HAND SANITIZER GEL- hand sanitizer gel

Instant Hand Sanitizer Gel by

Drug Labeling and Warnings

Instant Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Ganzhou Yuanling Medical Technology Co.,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

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

Do not use

• in 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.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask 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 Control Center right away.

Directions

• For children under age 6, use only under adult supervision.
• Put enough product in your palm to wet hands thoroughly and rub briskly untill dry without wiping.

Other information

• Store below 110℉ (43 ℃)

Inactive ingredients

Aloe Barbadensis Leaf Juice, Blue 1(CI 42090), Carbomer, Fragrance (Parfum), Glycerin, Triethanolamine, Tocopheryl Acetate, Water(Aqua), Yellow 5 (CI 19140)

Package Label - Principal Display Panel

50 mL NDC: 78301-050-01

Package Label - Principal Display Panel

100 mL NDC: 78301-050-02

Package Label - Principal Display Panel

250 mL NDC: 78301-050-05

Package Label - Principal Display Panel

500 mL NDC: 78301-050-10

Package Label - Principal Display Panel

1000 mL NDC: 78301-050-20

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER GEL 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78301-050
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
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.03 mL  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.00003 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.001 mL  in 100 mL
ALOE (UNII: V5VD430YW9)	0.01 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.00009 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.067 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E)	0.176 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	24.21588 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78301-050-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/09/2020
2	NDC: 78301-050-02	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/09/2020
3	NDC: 78301-050-05	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/09/2020
4	NDC: 78301-050-10	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/09/2020
5	NDC: 78301-050-20	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/09/2020

Labeler - Ganzhou Yuanling Medical Technology Co.,ltd (554535253)

Registrant - Ganzhou Yuanling Medical Technology Co.,ltd (554535253)

Establishment
Name	Address	ID/FEI	Business Operations
Ganzhou Yuanling Medical Technology Co.,ltd		554535253	manufacture(78301-050)