ORAJEL COLD SORE MOISTURELOCK- benzocaine cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z), CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)

Available from:

Church & Dwight Co., Inc.

INN (International Name):

BENZOCAINE

Composition:

BENZOCAINE 200 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Allantoin - Skin protectant Benzocaine - Topical anesthetic Camphor - Topical analgesic Dimethicone - Skin protectant Menthol - Topical analgesic White petrolatum - Skin protectant Uses • temporarily relieves pain and dryness; softens crusts (scabs) associated with • cold sores • fever blisters Do not use • more than directed • for more than 7 days unless directed by a physician 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

ORAJEL COLD SORE MOISTURELOCK- BENZOCAINE CREAM
CHURCH & DWIGHT CO., INC.
_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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ORAJEL COLD SORE MOISTURELOCK
Allantoin 0.5%
Benzocaine 20%
Camphor 3%
Dimethicone 2%
Menthol 1%
White petrolatum 64%
Allantoin - Skin protectant
Benzocaine - Topical anesthetic
Camphor - Topical analgesic
Dimethicone - Skin protectant
Menthol - Topical analgesic
White petrolatum - Skin protectant
USES • temporarily relieves pain and dryness; softens crusts (scabs)
associated with •
cold sores • fever blisters
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 • more than directed • for more than 7 days unless
directed by a
physician
WHEN USING THIS PRODUCT • do not get into eyes
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. 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 INGREDIENTS caprylic/capric triglyceride, Prunella vulgaris
leaf extract.
propylene glycol, water