drug facts

drug facts
SPL v2
SPL
SPL Set ID 6ca177d8-e0c3-4582-b45b-ff5ea7879e65
Route
topical
Published
Effective Date 2012-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (0.10 g) phenol (0.0135 g) camphor (synthetic) (0.03 g)
Inactive Ingredients
propylene glycol menthyl lactate, (-)- alcohol water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2009-02-01

Purpose

Analgesic, Anesthetic, Antipuritic First Aid Antiseptic External Analgesic

Description

Active Ingredients Benzocaine 10% Phenol 1.35% Camphor 3%


Medication Information

Warnings

For external use only.

Uses

First aid to help prevent infection in minor cuts, scrapes, and burns.

Purpose

Analgesic, Anesthetic, Antipuritic

First Aid Antiseptic

External Analgesic

Directions
  • Clean area
  • Apply a small amount to the bite area while massaging with sponge tip applicator.  If itching persists, apply again in 10-15 minutes
  • For ticks and bees, remove tick or stinger before treatment
  • Adults and children 2 years and over: Apply to affected area 1 to 3 times daily
  • Children under 2 years: Consult a doctor

Inactive Ingredients

Camphor, Menthyl lactate, Propylene Glycol, SD Alcohol 40B 20%, Water

Description

Active Ingredients Benzocaine 10% Phenol 1.35% Camphor 3%

Section 51945-4

Enter section text here

Drug Facts

Active Ingredients

Benzocaine 10%

Phenol 1.35%

Camphor 3%

Questions Or Comments?

1-800-558-6614

When Using This Product
  • Do not get in eyes
  • Do not apply over large areas of the body
  • In case of deep or puncture wounds, animal bites, or serious burns consult a doctor
  • Do not bandage.

Stop Use and Ask Doctor If

condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days.  Do not use longer than one week unless directed by a doctor.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a poison control center right away.  If in eyes, flush with water for 15 minutes and call a physician.


Structured Label Content

Warnings

For external use only.

Uses

First aid to help prevent infection in minor cuts, scrapes, and burns.

Purpose

Analgesic, Anesthetic, Antipuritic

First Aid Antiseptic

External Analgesic

Directions
  • Clean area
  • Apply a small amount to the bite area while massaging with sponge tip applicator.  If itching persists, apply again in 10-15 minutes
  • For ticks and bees, remove tick or stinger before treatment
  • Adults and children 2 years and over: Apply to affected area 1 to 3 times daily
  • Children under 2 years: Consult a doctor

Inactive Ingredients

Camphor, Menthyl lactate, Propylene Glycol, SD Alcohol 40B 20%, Water

Section 51945-4 (51945-4)

Enter section text here

Drug Facts

Active Ingredients

Benzocaine 10%

Phenol 1.35%

Camphor 3%

Questions Or Comments? (Questions or Comments?)

1-800-558-6614

When Using This Product (When using this product)
  • Do not get in eyes
  • Do not apply over large areas of the body
  • In case of deep or puncture wounds, animal bites, or serious burns consult a doctor
  • Do not bandage.

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

condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days.  Do not use longer than one week unless directed by a doctor.

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

If swallowed, get medical help or contact a poison control center right away.  If in eyes, flush with water for 15 minutes and call a physician.


Advanced Ingredient Data


Raw Label Data

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