APPLAUSE- instant hand sanitizer gel

Applause by

Drug Labeling and Warnings

Applause by is a Otc medication manufactured, distributed, or labeled by QuestSpecialty Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 60%..........Antiseptic

purpose

Antiseptic

Uses

• Handwash to help decrease bacterial on the skin.
• Recommended for repeated use.

Warnings

• Flammable. Keep away from fire or flame.
• For external use only.

do not use

• In the eyes

When Using

• Do not use in or near the eyes.
• If contact occurs, flush eyes with water for 15 minutes. Consult physician if irritatioin persists.
• If swallowed, seek medical assitance or consult a poison control cener immediately.

Stop Use

• Stop use and ask a doctor if: Irritation develops. If condtion persists for more than 72 hours consult a doctor.
• Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children.

Directions for Use

• Place a palmful ( 5 grams) of product in one hand,.
• Spread on both hands and rub into the skin until dry (approximately 1 to 2 minutes).
• Place a smaller amolunt (2.5 grams) into one hand, spread over both hands to wrist and rub into the skin until dry (approximately 30 seconds).
• Will air dry in 15 seconds.

OTHER SAFETY INFORMATION

• Store below 95 o F.
• Close spout to avoid evaporation.

INACTIVE INGREDIENT

Water, triethanolamine, fragrance, acrylic polymer

label jpg

INGREDIENTS AND APPEARANCE

APPLAUSE 
instant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67858-693
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	3 g  in 5 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67858-693-24	12 in 1 CARTON	10/02/2018
1	NDC: 67858-693-04	107 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/02/2018

Labeler - QuestSpecialty Corporation (103840377)

Registrant - QuestSpecialty Corporation (103840377)

Establishment
Name	Address	ID/FEI	Business Operations
QuestSpecialty Corporation		103840377	manufacture(67858-693)