CAREONE COLD SORE TREATMENT- camphor, menthol, phenol, white petrolatum gel 
American Sales Company

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.

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American Sales Company Cold Sore Treatment Drug Facts

Active ingredients

Camphor 3.00%

Menthol 1.00%

Phenol 1.50%

White Petrolatum 89.20%

Purpose

Cold sore/fever blister treatment

Skin Protectant

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

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 at 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
•
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

Other information

store at room temperature

Inactive ingredients

Eucalyptol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymol, Tocopheryl Nicotinate

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.

Package/Label Principal Display Panel

MAXIMUM STRENGTH

Camphor 3.00%, Menthol 1.00%, Phenol 1.50%, White Petrolatum 89.20%

COLD SORE TREATMENT

Cold Sore/Fever Blister Treatment & Skin Protectant

New & Improved

TEMPORARY RELIEF OF PAIN & DISCOMFORT

Paraben Free

With Tea Tree Oil

Medicated

Phthalate Free

Sulfate Free

Works on Contact

Applies Clear

OUR PHARMACISTS RECOMMEND

NET WT 0.07 oz (2.0 g)

CareOne Cold Sore Treatment
CAREONE COLD SORE TREATMENT 
camphor, menthol, phenol, white petrolatum gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-097
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL15 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM892 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
EUCALYPTOL (UNII: RV6J6604TK)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
THYMOL (UNII: 3J50XA376E)  
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-097-011 in 1 PACKAGE03/11/2020
12 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/11/2020
Labeler - American Sales Company (809183973)

Revised: 3/2020
Document Id: 3e17d865-424d-414d-83f5-4d89526d98da
Set id: 3e17d865-424d-414d-83f5-4d89526d98da
Version: 1
Effective Time: 20200311
 
American Sales Company