ANTISEPTIC HAND GEL- ethyl alcohol gel

Antiseptic Hand Gel by

Drug Labeling and Warnings

Antiseptic Hand Gel by is a Otc medication manufactured, distributed, or labeled by H and P Industries, Inc. dba Triad Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol, 70% v/v

PURPOSE

Antiseptic

USES

For handwashing when water is not available to decrease bacteria on the skin

• after changing diapers
• after assisting ill persons
• before contact with a person under medical care or treatment
• recommended for repeated use
  

WARNINGS

For external use only.
Flammable, keep away from fire or flame.

Do not use

in the eyes.

Stop use and ask a doctor

• if irritation and redness develop.
• if condition persists for more than 72 hours
  

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• Place a palmful of product in one hand
  
• Spread on both hands and rub into skin until dry (approx. 1-2 min.)
  
• Place a smaller amount into one hand
  
• Spread over hands to wrist and rub into skin until dry (approx. 30 sec.)
  

SPL UNCLASSIFIED SECTION

OTHER INFORMATION

Store at room temperature: 15°- 30° C (59° - 86° F)

INACTIVE INGREDIENTS

aloe vera gel, carbomer 940, denatonium benzoate, fragrance, PEG-1450, tert-butyl alcohol, triethanolamine, water

QUESTIONS

LABEL INFORMATION

Triad®

Cat. No. 10-8616
NDC: 50730-8616-5


Antiseptic
Hand Gel

Reduces the risk of bacterial contamination and infection
Helps meet CDC, OSHA and APIC Guidelines for Hand Hygiene
Contains Aloe Vera Gel

Triad Group, Inc.
700 West North Shore Drive
Hartland, WI 53029
MADE IN USA
www.triad-group.net

16 fl. oz. (472 ml)

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50730-8616
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	.70 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
carbomer homopolymer type c (UNII: 4Q93RCW27E)
denatonium benzoate (UNII: 4YK5Z54AT2)
polyethylene glycol 1450 (UNII: OJ4Z5Z32L4)
tert-butyl alcohol (UNII: MD83SFE959)
trolamine (UNII: 9O3K93S3TK)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50730-8616-5	472 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	11/17/1997

Labeler - H and P Industries, Inc. dba Triad Group (050259597)

Registrant - H and P Industries, Inc. dba Triad Group (050259597)

Establishment
Name	Address	ID/FEI	Business Operations
H and P Industries, Inc. dba Triad Group		050259597	manufacture