ORAJEL TOOTHACHE RINSE- benzyl alcohol, zinc chloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH), ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Church & Dwight Co., Inc.

INN (International Name):

BENZYL ALCOHOL

Composition:

BENZYL ALCOHOL 2.91 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Oral pain reliever Oral astringent Use for temporary relief of pain due to toothaches, minor irritation of the mouth and gums, occasional minor irritation, pain, sore mouth and sore throat Stop use and see your physician promptly if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days • allergic reaction occurs • sore thoat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ORAJEL TOOTHACHE RINSE- BENZYL ALCOHOL, ZINC CHLORIDE LIQUID
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 TOOTHACHE RINSE
Benzyl Alcohol 0.27%
Zinc Chloride 0.15%
Oral pain reliever
Oral astringent
USE for temporary relief of pain due to toothaches, minor irritation
of the mouth and
gums, occasional minor irritation, pain, sore mouth and sore throat
WARNINGS
DO NOT USE this product for more than 7 days unless directed by a
dentist or
healthcare provider
WHEN USING THIS PRODUCT • do not swallow • do not exceed
recommended dosage
STOP USE AND SEE YOUR PHYSICIAN PROMPTLY IF • swelling, rash or
fever develops •
irritation, pain or redness persists or worsens • sore mouth
symptoms do not improve
in 7 days • allergic reaction occurs • sore thoat is severe,
persists for more than 2 days,
is accompanied or followed by fever, headache, rash, nausea, or
vomiting.
KEEP OUT OF REACH OF CHILDREN. If more than used for rinsing is
accidentally
swallowed, get medical help or contact a Poison Control Center right
away
DIRECTIONS
• remove imprinted safety seal from bottle cap
• to remove child-resistant cap, squeeze smooth sides of cap while
turning. Reclose
tightly. Ready to use, no mixing needed.
Adults and children 2 years of age or over:
Swish one-half capful (2 teaspoons = 10mL) around the mouth over the
affected area
for at least 1 minute and then spit out. Use up to 4 times daily after
meals and at
bedtime or as directed by a dentist or healthcare provider
Children under 12 years of age:
Should be supervised in the use of this product
Children under 2 years of age:
Consult a dentist or healthcare provider
OTHER INFORMATION • cap tightly • keep away from heat or direct
sunlight • do not use
if safety seal is broken or missing
INACTIVE INGREDIENTS alcohol (4.1% by volume), blue 1, disodium
pyropho