Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 38899205-1463-4c07-a2d6-fdbe57fb5a9f
Route
TOPICAL
Published
Effective Date 2012-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Alcohol Aloe Vera Leaf Arginine Butylparaben Camphor (synthetic) Cetearyl Isononanoate Dipropylene Glycol Caprate/caprylate Diester Ethylparaben Corymbia Citriodora Leaf Oil Hexyldecanol Hexyldecyl Laurate Levomenthol Methylparaben Ceresin Tea Tree Oil Poloxamer 407 Propylparaben Alpha-tocopherol Thymol Zinc Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-01-01

Description

Benzalkonium Chloride 0.13%

Purpose

Cold Sore/Fever Blister Treatment/First Aid Antiseptic


Medication Information

Purpose

Cold Sore/Fever Blister Treatment/First Aid Antiseptic

Description

Benzalkonium Chloride 0.13%

Uses


  • For treatment of cold sores/fever blisters on the face or lips
  • Helps relieve the symptoms of itching, burning and pain associated with cold sores/fever blisters in just one day
  • Relieves dryness and softens cold sores and fever blisters
  • First aid to help protect against infection in minor cuts, scrapes, burns, and sores

Section 50565-1

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

Section 51945-4

Warnings
  • For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.
  • Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.
  • When using this product avoid contact with eyes. Use only as directed.
  • Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 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. (1-800-222-1222)

Directions


  • Clean the affected area
  • Apply a small amount of this product to the affected area 1 to 3 times daily
  • Rub in gently
  • Wash hands before and after applying cream
  • Do not share this product with anyone
  • Children under 12 years of age: ask a doctor
Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Store at room temperature

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Juice, Arginine, Butylparaben, Camphor, Cetearylisononanoate, Dipropylenglycole Dicaprylate-Dicaprate, Ethylparaben, Eucalyptus Globulus Leaf Oil, Hexyldecanole, Hexyl Decyl Laurate, Menthol,

Methylparaben, Ozokerite, Phenoxyethanol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Poloxamer 407, Propylparaben, Tocopheryl Nicotinate (Vitamin E), Thymol, Zinc Chloride

Questions Or Comments?

Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.

Serious side effects associated with use of this product may be reported to this number.


Structured Label Content

Uses


  • For treatment of cold sores/fever blisters on the face or lips
  • Helps relieve the symptoms of itching, burning and pain associated with cold sores/fever blisters in just one day
  • Relieves dryness and softens cold sores and fever blisters
  • First aid to help protect against infection in minor cuts, scrapes, burns, and sores

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Purpose

Cold Sore/Fever Blister Treatment/First Aid Antiseptic

Warnings
  • For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.
  • Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.
  • When using this product avoid contact with eyes. Use only as directed.
  • Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 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. (1-800-222-1222)

Directions


  • Clean the affected area
  • Apply a small amount of this product to the affected area 1 to 3 times daily
  • Rub in gently
  • Wash hands before and after applying cream
  • Do not share this product with anyone
  • Children under 12 years of age: ask a doctor
Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Store at room temperature

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Juice, Arginine, Butylparaben, Camphor, Cetearylisononanoate, Dipropylenglycole Dicaprylate-Dicaprate, Ethylparaben, Eucalyptus Globulus Leaf Oil, Hexyldecanole, Hexyl Decyl Laurate, Menthol,

Methylparaben, Ozokerite, Phenoxyethanol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Poloxamer 407, Propylparaben, Tocopheryl Nicotinate (Vitamin E), Thymol, Zinc Chloride

Questions Or Comments? (Questions or Comments?)

Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.

Serious side effects associated with use of this product may be reported to this number.


Advanced Ingredient Data


Raw Label Data

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