1407 Medicaine Insect Bite (Ampule) 67777-405-01

Active Ingredient

Benzocaine USP 20%

Purpose

Analgesic

Active Ingredient

L-Menthol USP 1%

Purpose

Analgesic

Use(s)

For the temporary relief of pain and itching associated with insect bites and stings.

Warnings

For External Use Only

When Using Section

• Do not use in the eyes

• Not for prolonged use

• Do not apply other medication to the same affected areas unless advised by a doctor

Stop use and ask a doctor if

Condition persists, or if a rash, irritation, or allergic reaction develops.

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Once solution has saturated tip, apply topically to the sting or bit. May be used on affected area(s) up to 4 times per day

Not for use with children less than 2 years old without medical advise.

Other Information

Store at room temperature 15º-30ºC (59º-86ºF) away from light.

Inactive Ingredients

D&C Green Dye #5, D&C Yellow Dye #10, FD&C Blue Dye #1, Isopropyl Alcohol, PEG 300 NF, Purified Water USP

medicaine sting and bit ampules latex free box label

MEDICAINE STING AND BITE
benzocaine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67777-405
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.12 g in 0.6 mL

Ingredient Name	Strength
Inactive Ingredients
MENTHOL (UNII: L7T10EIP3A)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67777-405-03	50 in 1 CASE	02/14/1976
1	NDC:67777-405-02	10 in 1 BOX
1	NDC:67777-405-01	6 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	02/14/1976

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124529)

Revised: 4/2024

Document Id: 15e66468-1827-f42f-e063-6294a90ad6da

Set id: b721607e-e36b-4691-a824-c8f520bd6386

Version: 4

Effective Time: 20240412

Dynarex Corporation