FDA Label for Maximum Strength Cold Sore Treatment
View Indications, Usage & Precautions
Maximum Strength Cold Sore Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Retail Business Services, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients Purpose
Camphor 3.00%
Menthol 1.00%
Phenol 1.50%
White Petrolatum 89.20%
Otc - Purpose
Purpose
Cold sore/fever blister treatment
Cold sore/fever blister treatment
Cold sore/fever blister treatment
Skin Protectant
Otc - When Using
Uses
• For treatment of cold sores/fever blisters on the face or lips
• Temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters
• Temporarily protects minor cuts, scrapes, burns, and sores
• Helps prevent and temporarily protects chapped or cracked skin and lips
Warnings
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.
Other Safety Information
Other information store at room temperature
Inactive Ingredient
Inactive ingredients Eucalyptol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymol,
Tocopheryl Nicotinate
Otc - Questions
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.
Otc - 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
at 1-800-222-1222.
Indications & Usage
Directions
• Clean the affected area • Apply a small amount of this product to the affected area 1 to 3 times daily
• Rub in gently • May be covered with a sterile bandage • Wash hands before and after applying cream
• Do not share this product with anyone • Children under 12 years of age: ask a doctor
Recent Major Changes
Indications and Usage
Section added 06/26/2019
Dosage and Administration
Section added 06/26/2019
Dosage & Administration
Apply a small amount of this product to the affected area 1 to 3 times daily
Cold Sore Tube Card Pdp
CAREone
Maximum Strength
Camphor 3.00%, Menthol 1.00%, Phenol 1.50%, White Petrolatum 89.20%
Cold Sore Treatment
cold sore/fever blister treatment and skin protectant
new & improved
Temporary Relief of Pain & Discomfort
Paraben Free*
With Tea Tree Oil
Medicated
Phthalate Free**
Sulfate Free
Works on Contact
Applied Clear
NET WT 0.07 OZ ( 2.0 g)
*Free from Methylparaben, Ethylparaben, Propylparaben and Butylparaben
**tested per CPSC-CH-C1001.09.3
DISTRIBUTED BY:
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
For product questions or concerns, contact us at 1-877-846-9949
©2020 Ahold Delhaize Licensing Sarl
Quality guaranteed or your money back.
* Please review the disclaimer below.