HAND SANITIZER GEL- hand sanitizer gel

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Guangxi Qingrong Hygiene&disinfection Products Co.,ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store in cool and dry environment, keep sealed below 43C (110F).

Inactive ingredients

aloe, carbomer, fragrance, glycerin, isopropyl alcohol, propylene glycol, sorbitol, sterile distilled water, triethanolamine.

Package Label - Principal Display Panel

60 mL NDC: 80001-881-06

Package Label - Principal Display Panel

250 mL NDC: 80001-881-25

Package Label - Principal Display Panel

500 mL NDC: 80001-881-50

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80001-881
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
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	24.15 mL  in 100 mL
ALOE (UNII: V5VD430YW9)	1 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.24 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.1 mL  in 100 mL
SORBITOL (UNII: 506T60A25R)	0.5 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.01 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80001-881-06	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/14/2020
2	NDC: 80001-881-25	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/14/2020
3	NDC: 80001-881-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/14/2020

Labeler - Guangxi Qingrong Hygiene&disinfection Products Co.,ltd. (554544649)

Registrant - Guangxi Qingrong Hygiene&disinfection Products Co.,ltd. (554544649)

Establishment
Name	Address	ID/FEI	Business Operations
Guangxi Qingrong Hygiene&disinfection Products Co.,ltd.		554544649	manufacture(80001-881)