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

1407 Medicaine Insect Bite (ampule) 67777-405-01
SPL v5
SPL
SPL Set ID b721607e-e36b-4691-a824-c8f520bd6386
Route
TOPICAL
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (0.12 g)
Inactive Ingredients
Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1976-02-14

Description

Benzocaine USP 20%

Purpose

Analgesic


Medication Information

Purpose

Analgesic

Description

Benzocaine USP 20%

Label

1407 Medicaine Sting and Bite Ampule

Use(s)

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

Warnings

For External Use Only

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.

Active Ingredient

Benzocaine USP 20%

Other Information

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

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

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

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.


Structured Label Content

Label

1407 Medicaine Sting and Bite Ampule

Use(s)

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

Purpose

Analgesic

Warnings

For External Use Only

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.

Active Ingredient

Benzocaine USP 20%

Other Information

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

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

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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