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NDC 69842-0695-00 Cold Sore Treatment 30; 10; 892; 15 mg/g; mg/g; mg/g; mg/g Details

Cold Sore Treatment 30; 10; 892; 15 mg/g; mg/g; mg/g; mg/g

Cold Sore Treatment is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PETROLATUM; PHENOL.

Product Information

NDC	69842-0695
Product ID	69842-695_83b6c762-ae49-4ed8-bb5b-010176af9f44
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cold Sore Treatment
Proprietary Name Suffix	n/a
Non-Proprietary Name	Camphor, Menthol, Phenol, White Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	30; 10; 892; 15
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PETROLATUM; PHENOL
Labeler Name	CVS Pharmacy
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0695-00 (69842069500)

Pricing Information	N/A
NDC Package Code	69842-695-00
Billing NDC	69842069500
Package	1 BOTTLE, PUMP in 1 PACKAGE (69842-695-00) / 2 g in 1 BOTTLE, PUMP
Marketing Start Date	2020-06-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 83b6c762-ae49-4ed8-bb5b-010176af9f44 Details

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

Easy-to-Use Pump

MAXIMUM STRENGTH

CAMPHOR 3.00%, MENTHOL 1.00%, PHENOL 1.50%, WHITE PETROLATUM 89.20%

Cold Sore Treatment

Temporary Relief of Pain & Discomfort

Works on Contact

Applies Clear

Cold sore/fever blister treatment & skin protectant

PARABEN FREE

PHTHALATE FREE

NET WT 0.07 OZ (2.0 g)

INGREDIENTS AND APPEARANCE

COLD SORE TREATMENT

camphor, menthol, phenol, white petrolatum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-695
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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 FORM	10 mg in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	15 mg in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	892 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
EUCALYPTOL (UNII: RV6J6604TK)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
THYMOL (UNII: 3J50XA376E)
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-695-00	1 in 1 PACKAGE	06/24/2020
1		2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC:69842-695-01	1 in 1 PACKAGE	08/04/2020
2		2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/24/2020

Labeler - CVS Pharmacy (062312574)

Revised: 2/2021

Document Id: 83b6c762-ae49-4ed8-bb5b-010176af9f44

Set id: 83b6c762-ae49-4ed8-bb5b-010176af9f44

Version: 1

Effective Time: 20210208