RINSE-FREE HAND SANITIZER gel

Rinse-free Hand Sanitizer by

Drug Labeling and Warnings

Rinse-free Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ningbo Haishu Huasen Houseware Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

To decrease bacteria on the skin that could cause diseasee.
Recommended for repeated use.

Warnings

For external use only.
Flammable. Keep away from heat and flame.
Discontinue if skin becomes irritated and ask a doctor.
Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Do not use

Do not inhale or ingest..

Do not store above 105°F.

WHEN USING

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
Do not inhale or ingest.
Avoid contact with broken skin.

STOP USE

/

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Directions

Wet hands thoroughly with product and rub until dry without wiping.
For children under 6, use only under adult supervisiono.
Not recommended for infants

Other information

Do not store above 105°F
May discolor some fabrics
Harmful to wood finishes and plastics

Inactive ingredients

Water, glycerin, propylene glycol, carbomer, sodium hydroxide

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

RINSE-FREE HAND SANITIZER 
rinse-free hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78345-006
Route of Administration	TOPICAL, CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 1342 (UNII: 809Y72KV36)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TROLAMINE (UNII: 9O3K93S3TK)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78345-006-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78345-006-02	500 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 - Ningbo Haishu Huasen Houseware Co.,Ltd (554532212)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Haishu Huasen Houseware Co.,Ltd		554532212	manufacture(78345-006)