CUT CARE INSECT BITE ANTISEPTIC AND PAIN RELIEVING WIPE- benzocaine and isopropyl alcohol swab
Zeus Medical Holdings LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Cut Care Insect Bite Antiseptic and Pain Relieving Wipes

Active Ingredients

Benzocaine, 6% w/v

Purpose

Topical Analgesic

Active Ingredients

Isopropyl Alcohol, 70% w/v

Purpose

Antiseptic

Uses

For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Warnings

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

Do Not Use

With electrocautery procedures.
In eyes

Stop Use

If irritation and redness develop.
If condition persists for more than 72 hours, consult a physician.

Keep out of Reach of Children.

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

Directions

Adults and children 2 years of age and older, apply to affected area 3-4 times daily.
Children under 2 years; consult a physician.

Other Information

Avoid excessive heat. Store at room temperature: 15 - 30 degrees C (59 - 86 degrees F)

Inactive Ingredient:

purified water

PRINCIPAL DISPLAY PANEL

NDC 53439-120-10
Cut Care
Insect Bite Antiseptic & Pain Relieving Wipes
First aid antiseptic
Topical Analgesic
Contents: 100 Pre-Moistened Wipes

CUT CARE INSECT BITE ANTISEPTIC AND PAIN RELIEVING WIPE
benzocaine and isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53439-120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	.021 g
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:53439-120-10	100 in 1 CARTON
1	NDC:53439-120-01	1 in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	09/15/2013

Labeler - Zeus Medical Holdings LLC (014884052)