ASSURED HAND SANITIZER WITH ALOE VERA- ethyl alcohol liquid

Assured by

Drug Labeling and Warnings

Assured by is a Otc medication manufactured, distributed, or labeled by Greenbrier International Inc., Ningbo Pulisi Daily Chemical Products Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 62%

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

Uses hand sanitizer to help reduce bacteria on the skin recommended for repeated use.

WARNINGS

Warnings Flammable. Keep away from fire and flame. For external use only

WHEN USING

When using this product avoid contact with eyes in case of eye contact immediately flush eyes with water, call a doctor avoid contact with broken skin.
Discontinue use if irritation develops. If condition persists for more than 72 hours, consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. Children should only use this product under adult supervision. Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

Other information do not store above 105F. May discolor some fabrics. Harmful to wood finishes and plastics

DOSAGE & ADMINISTRATION

Directions place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. recommended for repeated use

INACTIVE INGREDIENT

Inactive ingredients aloe barbadensis gel, carbomer, fragrance, FD&C blue no. 1, FD&C yellow no.5, glycerin, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, triethanolamine, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED  HAND SANITIZER WITH ALOE VERA
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-4948
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-4948-8	236 mL in 1 BOTTLE, PUMP
2	NDC: 33992-4948-1	295 mL in 1 BOTTLE, PUMP
3	NDC: 33992-4948-2	355 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2012

Labeler - Greenbrier International Inc. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Pulisi Daily Chemical Products Co.,Ltd.		529047265	manufacture(33992-4948)