ANBESOL COLD SORE THERAPY

Main information

  • Trade name:
  • ANBESOL COLD SORE THERAPY- allantion, benzocaine, camphor, petrolatum ointment
  • Composition:
  • ALLANTOIN 10 mg in 1 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANBESOL COLD SORE THERAPY- allantion, benzocaine, camphor, petrolatum ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • - temporarily relieves pain associated with fever blisters and cold sores - relieves dryness and softens fever blisters and cold sores

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 0573-0246-25, 0573-0246-26
  • Last update:
  • 22-06-2019

Summary of Product characteristics: dosage, interactions, side effects

ANBESOL COLD SORE THERAPY- allantion, benzocaine, camphor, petrolatum ointment

Wyeth Consumer Healthcare 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.

----------

Anbes ol

Cold Sore Therapy

Drug Facts

Active ingredients

Purposes

Allantoin 1%

Skin protectant

Benzocaine 20%

Fever blister/cold sore

treatment

Camphor 3%

Fever blister/cold sore

treatment

White petrolatum 64.9%

Skin protectant

Uses

temporarily relieves pain associated with fever blisters and cold sores

relieves dryness and softens fever blisters and cold sores

Warnings

METHEMOGLOBINEMIA WARNING

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly

because it reduces the amount of oxygen carried in blood. This can occur even if you have used this

product before. Stop use and seek immediate medical attention if you or a child in your care develops:

pale, gray, or blue colored skin (cyanosis)

headache

rapid heart rate

shortness of breath

dizziness or lightheadedness

fatigue or lack of energy

For external use only

Allergy alert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine,

benzocaine, or other "caine" anesthetics.

Do not use

on deep or puncture wounds

on animal bites

on serious burns

for teething

in children under age 2

When using this product

avoid contact with the eyes

®

do not exceed recommended dosage

Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

to open tube, cut tip of the tube on score mark with scissors

adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times

daily

children under 12 years of age: adult supervision should be given in the use of this product

children under 2 years of age: do not use

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

aloe barbadensis leaf extract, benzyl alcohol, butylparaben, glyceryl monostearate, isocetyl stearate,

menthol, methylparaben, mineral oil, propylparaben, sodium lauryl sulfate, vitamin E, white wax

Questions or comments?

Call weekdays 9AM to 5PM EST at 1-888-797-5638

PRINCIPAL DISPLAY PANEL - 9 g Tube Label

Anbesol

Cold Sore THERAPY

MAXIMUM STRENGTH

Fever Blister/

Cold Sore

Treatment

ointment

NET WT

0.33 OZ

(9 g)

PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack Label

ointment

WITH

Vitamin E

& Aloe

See new warnings information

Anbesol

Fever Blister/Cold Sore Treatment

Cold Sore THERAPY

MAXIMUM

STRENGTH

DOCTOR

RECOMMENDED

Instant

Pain Relief

NET WT 0.33 OZ (9 g)

Safety Sealed Tube:

Do Not Use if tube tip is cut prior to opening.

Cold Sores and

Fever Blisters

Moisturizes While It

Treats and Protects

ANBESOL COLD SORE THERAPY

allantion, benzocaine, camphor, petrolatum ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 573-0 246

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALLANTO IN (UNII: 344S277G0 Z) (ALLANTOIN - UNII:344S277G0 Z)

ALLANTOIN

10 mg in 1 g

20 0 mg

Wyeth Consumer Healthcare LLC

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

20 0 mg

in 1 g

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -

UNII:5TJD8 2A1ET)

CAMPHOR

(SYNTHETIC)

30 mg in 1 g

PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)

PETROLATUM

6 49 mg

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

ISO CETYL STEARATE (UNII: 3RJ718 6 O9 W)

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

MINERAL O IL (UNII: T5L8 T28 FGP)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

WHITE WAX (UNII: 7G1J5DA9 7F)

Product Characteristics

Color

WHITE (White o intment)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 573-0 246 -25

1 in 1 BLISTER PACK

0 5/0 9 /20 0 6

0 6 /21/20 10

1

9 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 573-0 246 -26

1 in 1 BLISTER PACK

0 9 /15/20 0 8

2

9 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 5/0 9 /20 0 6

Labeler -

Wyeth Consumer Healthcare LLC (828831730)

Revised: 9/2018