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NDC 69536-0108-23 Campho-Phenique 10.8; 4.7 g/100g; g/100g Details

Campho-Phenique 10.8; 4.7 g/100g; g/100g

Campho-Phenique is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Foundation Consumer Healthcare LLC. The primary component is CAMPHOR (SYNTHETIC); PHENOL.

Product Information

NDC	69536-0108
Product ID	69536-108_8fe320b6-b4dd-4a46-b364-8ca4e775dab3
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	Campho-Phenique
Proprietary Name Suffix	Cold Sore Treatment
Non-Proprietary Name	CAMPHOR (SYNTHETIC) and PHENOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	10.8; 4.7
Active Ingredient Units	g/100g; g/100g
Substance Name	CAMPHOR (SYNTHETIC); PHENOL
Labeler Name	Foundation Consumer Healthcare LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69536-0108-23 (69536010823)

Pricing Information	N/A
NDC Package Code	69536-108-23
Billing NDC	69536010823
Package	1 TUBE in 1 CARTON (69536-108-23) / 6.5 g in 1 TUBE
Marketing Start Date	2017-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 106c0bb2-f2e2-4255-867d-d09ff6a5a2e6 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Camphorated phenol (camphor 10.8% and phenol 4.7%)

Purposes

Pain reliever/antiseptic

Uses

for temporary relief of pain and itching associated with cold sores and fever blisters
first aid to help prevent infection

Warnings

For external use only

Do not use

over large areas of the body
with a bandage

Ask a doctor before use if you have

a deep or puncture wound
animal bites
serious burns

When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or 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. Do not induce vomiting before contacting medical help or a Poison Control Center.

Directions

adults and children 2 years of age and over:
- clean the affected area
- apply a small amount of this product to the cold sore or fever blister 1 to 3 times daily
- do not bandage
children under 2 years of age: ask a doctor

Other information

store at room temperature. Avoid excessive heat above 40°C (104°F).
close cap tightly after use

Inactive ingredients

light mineral oil, colloidal silicon dioxide, aloe barbadensis leaf extract, glycerin, eucalyptus oil

Questions or comments?

1-855-602-2676 weekdays 9 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

Dist. by:

Foundation Consumer Healthcare, LLC.

Pittsburgh, PA 15205

PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton

with

aloe

MAXIMUM STRENGTH

MEDICATED

CAMPHO

PHENIQUE®

COLD SORE

TREATMENT GEL

Fights cold sores with a powerful formula to:

immediately relieve

pain & itch

dry

cold sore

moisturize

surrounding area

Helps prevent infection

NET WT 0.23 OZ (6.5 g)

PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton

INGREDIENTS AND APPEARANCE

CAMPHO-PHENIQUE COLD SORE TREATMENT

camphor (synthetic) and phenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69536-108
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	10.8 g in 100 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	4.7 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
Aloe Vera Leaf (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69536-108-23	1 in 1 CARTON	08/01/2017
1		6.5 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	part348	08/01/2017

Labeler - Foundation Consumer Healthcare LLC (079675882)

Revised: 10/2021

Document Id: 8fe320b6-b4dd-4a46-b364-8ca4e775dab3

Set id: 106c0bb2-f2e2-4255-867d-d09ff6a5a2e6

Version: 3

Effective Time: 20211029

Search by Drug Name or NDC

NDC 69536-0108-23 Campho-Phenique 10.8; 4.7 g/100g; g/100g Details

Campho-Phenique 10.8; 4.7 g/100g; g/100g

Product Information

Package

Package Images

NDC 69536-0108-23 (69536010823)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 106c0bb2-f2e2-4255-867d-d09ff6a5a2e6 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purposes

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton

INGREDIENTS AND APPEARANCE

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