HAND SANITIZER- benzalkonium chloride gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by AMERICAN SALES COMPANY, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.1%

PURPOSE

ANTIMICROBIAL

USES

TO HELP REDUCE BACTERIA ON THE SKIN.  RECOMMENDED FOR REPEAT USE.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR RASH DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.
• CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.
  

INACTIVE INGREDIENTS

WATER, POLYQUATERNIUM-37, HYDROXYETHYLCELLULOSE, PEG-40 HYDROGENATED CASTOR OIL, TRIDECETH-9, PROPYLENE GLYCOL, FRAGRANCE, TRIETHANOLAMINE.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-280
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
TRIDECETH-9 (UNII: X9HD79I514)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-280-08	236 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/06/2011

Labeler - AMERICAN SALES COMPANY (809183973)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture