ORAJEL COLD SORE MOISTURELOCK- benzocaine cream

Orajel Cold Sore Moisturelock by

Drug Labeling and Warnings

Orajel Cold Sore Moisturelock by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., Accupac. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Allantoin 0.5%

Benzocaine 20%

Camphor 3%

Dimethicone 2%

Menthol 1%

White petrolatum 64%

PURPOSE

Allantoin - Skin protectant

Benzocaine - Topical anesthetic

Camphor - Topical analgesic

Dimethicone - Skin protectant

Menthol - Topical analgesic

White petrolatum - Skin protectant

INDICATIONS & USAGE

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

WARNINGS

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

DO NOT USE

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

WHEN USING

When using this product do not get into eyes

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

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

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

ORAJEL COLD SORE MOISTURELOCK 
benzocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-761
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg  in 1 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	30 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	640 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PRUNELLA VULGARIS LEAF (UNII: 2LW0610U4O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CORN OIL (UNII: 8470G57WFM)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-761-01	1 in 1 CARTON	07/01/2016
1		3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/01/2016

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac		071609663	manufacture(10237-761)