Orajel Cold Sore Moisturelock

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (200 mg) Allantoin (5 mg) Camphor (natural) (30 mg) Dimethicone (20 mg) Menthol (10 mg) Petrolatum (640 mg)

Inactive Ingredients

Medium-chain Triglycerides Prunella Vulgaris Leaf Titanium Dioxide Fd&c Yellow No. 5 Propylene Glycol .alpha.-tocopherol Acetate Vitamin A Palmitate Corn Oil Cholecalciferol Ferric Oxide Red Fd&c Blue No. 1 Tocopherol

Identifiers & Packaging

Pill Appearance

Color: green

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-07-01

Medication Information

Warnings and Precautions

For external use only.

Allergy alert:do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Indications and Usage

Uses •temporarily relieves pain and dryness; softens crusts (scabs) associated with • cold sores • fever blisters

Description

Allantoin 0.5% Benzocaine 20% Camphor 3% Dimethicone 2% Menthol 1% White petrolatum 64%

Section 50565-1

Keep out of reach of children.In case of overdose or allergic reaction, get medical help or contact Poison Control Center right away.

Section 50566-9

Stop use and ask a physician if• conditions worsens • symptoms do not improve in 7 days • symptoms clear up and occur again within a few days • swelling, rash or fever develops • irritation, pain or redness persists or worsens

Section 50567-7

When using this product• do not get into eyes

Section 50570-1

Do not use •more than directed • for more than 7 days unless directed by a physician

Section 51727-6

Inactive Ingredientscaprylic/capric triglyceride, Prunella vulgaris leaf extract. propylene glycol, water, tocopheryl acetate, retinyl palmitate, Zea mays (corn) oil, tocopherol, cholecalciferol, titanium dioxide, yellow 5 lake, iron oxides, blue 1 lake

Section 51945-4

Orajel

Instan Pain Relief

FOR COLD SORES

MOISTURELOCK FORMULA

Helps Speed Healing

Treats 6 Symptoms:

1 Pain

2 Itching

3 Redness

4 Scabbing

5 Cracking

6 Dryness

PLUS

Helps Minimize Appearance of Cold Sores

Topical Anesthetic/Topical

Analgesic/Skin Protectant

NET WT 0.105 OZ (3g)

Section 53413-1

Questions or commentscall us at 800 952 5080 Monday through Friday 9 to 5 ET or visit www orajel com

Section 55105-1

Allantoin - Skin protectant

Benzocaine - Topical anesthetic

Camphor - Topical analgesic

Dimethicone - Skin protectant

Menthol - Topical analgesic

White petrolatum - Skin protectant

Section 55106-9

Allantoin 0.5%

Benzocaine 20%

Camphor 3%

Dimethicone 2%

Menthol 1%

White petrolatum 64%

Directions

• squeeze tube to dispense • blend well until green tint disappears • rub in gently

Adults and children 2 years of age and older | Apply to affected area not more than 3 to 4 times daily

Children under 12 years of age | Should be supervised in the use of this product

Children under 2 years of age | Ask a physician

Other information • do not use if the package is torn, cut or otherwise damaged • store at 15-30ºC (59-86º) under dry conditions • this is a personal care item and should be used by one individual only

Structured Label Content

Indications and Usage (34067-9)

Uses •temporarily relieves pain and dryness; softens crusts (scabs) associated with • cold sores • fever blisters

Warnings and Precautions (34071-1)

For external use only.

Allergy alert:do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose or allergic reaction, get medical help or contact Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a physician if• conditions worsens • symptoms do not improve in 7 days • symptoms clear up and occur again within a few days • swelling, rash or fever develops • irritation, pain or redness persists or worsens

Section 50567-7 (50567-7)

When using this product• do not get into eyes

Section 50570-1 (50570-1)

Do not use •more than directed • for more than 7 days unless directed by a physician

Section 51727-6 (51727-6)

Inactive Ingredientscaprylic/capric triglyceride, Prunella vulgaris leaf extract. propylene glycol, water, tocopheryl acetate, retinyl palmitate, Zea mays (corn) oil, tocopherol, cholecalciferol, titanium dioxide, yellow 5 lake, iron oxides, blue 1 lake

Section 51945-4 (51945-4)

Orajel

Instan Pain Relief

FOR COLD SORES

MOISTURELOCK FORMULA

Helps Speed Healing

Treats 6 Symptoms:

1 Pain

2 Itching

3 Redness

4 Scabbing

5 Cracking

6 Dryness

PLUS

Helps Minimize Appearance of Cold Sores

Topical Anesthetic/Topical

Analgesic/Skin Protectant

NET WT 0.105 OZ (3g)

Section 53413-1 (53413-1)

Questions or commentscall us at 800 952 5080 Monday through Friday 9 to 5 ET or visit www orajel com

Section 55105-1 (55105-1)

Allantoin - Skin protectant

Benzocaine - Topical anesthetic

Camphor - Topical analgesic

Dimethicone - Skin protectant

Menthol - Topical analgesic

White petrolatum - Skin protectant

Section 55106-9 (55106-9)

Allantoin 0.5%

Benzocaine 20%

Camphor 3%

Dimethicone 2%

Menthol 1%

White petrolatum 64%

Directions

• squeeze tube to dispense • blend well until green tint disappears • rub in gently

Adults and children 2 years of age and older | Apply to affected area not more than 3 to 4 times daily

Children under 12 years of age | Should be supervised in the use of this product

Children under 2 years of age | Ask a physician

Other information • do not use if the package is torn, cut or otherwise damaged • store at 15-30ºC (59-86º) under dry conditions • this is a personal care item and should be used by one individual only

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses • temporarily relieves pain and dryness; softens crusts (scabs) associated with • cold sores • fever blisters", "34071-1": "For external use only. Allergy alert: do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics", "50565-1": "Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact Poison Control Center right away.", "50566-9": "Stop use and ask a physician if • conditions worsens • symptoms do not improve in 7 days • symptoms clear up and occur again within a few days • swelling, rash or fever develops • irritation, pain or redness persists or worsens", "50567-7": "When using this product • do not get into eyes", "50570-1": "Do not use • more than directed • for more than 7 days unless directed by a physician", "51727-6": "Inactive Ingredients caprylic/capric triglyceride, Prunella vulgaris leaf extract. propylene glycol, water, tocopheryl acetate, retinyl palmitate, Zea mays (corn) oil, tocopherol, cholecalciferol, titanium dioxide, yellow 5 lake, iron oxides, blue 1 lake", "51945-4": "Orajel Instan Pain Relief FOR COLD SORES MOISTURELOCK FORMULA Helps Speed Healing Treats 6 Symptoms: 1 Pain 2 Itching 3 Redness 4 Scabbing 5 Cracking 6 Dryness PLUS Helps Minimize Appearance of Cold Sores Topical Anesthetic/Topical Analgesic/Skin Protectant NET WT 0.105 OZ (3g)", "53413-1": "Questions or comments call us at 800 952 5080 Monday through Friday 9 to 5 ET or visit www orajel com", "55105-1": "Allantoin - Skin protectant Benzocaine - Topical anesthetic Camphor - Topical analgesic Dimethicone - Skin protectant Menthol - Topical analgesic White petrolatum - Skin protectant", "55106-9": "Allantoin 0.5% Benzocaine 20% Camphor 3% Dimethicone 2% Menthol 1% White petrolatum 64%", "Directions": "• squeeze tube to dispense • blend well until green tint disappears • rub in gently Adults and children 2 years of age and older | Apply to affected area not more than 3 to 4 times daily Children under 12 years of age | Should be supervised in the use of this product Children under 2 years of age | Ask a physician Other information • do not use if the package is torn, cut or otherwise damaged • store at 15-30ºC (59-86º) under dry conditions • this is a personal care item and should be used by one individual only"}

Orajel Cold Sore Moisturelock

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information