ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES- hydrogen peroxide 1.5%, menthol 0.1% liquid

Orajel Antiseptic Rinse by

Drug Labeling and Warnings

Orajel Antiseptic Rinse by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Canada Corp., Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Hydrogen peroxide 1.5%

Menthol 0.1%

PURPOSE

Purpose

Oral debriding agent/Oral antiseptic

Oral pain reliever

INDICATIONS & USAGE

Uses

• first aid to help reduce bacteria in minor oral wounds
• for temporary pain relief and
• use in cleansing minor wounds or minor gum inflammation resulting from:
• minor dental procedures
• accidental injury
• orthodontic appliances
• canker sores
• dentures
• other irritations of the mouth and gums

Aids in the removal of

• phlegm
• mucus
• other secretions associated with occasional sore mouth

WARNINGS

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

Stop Use and see your physician promptly if

• swelling, rash or fever develops
• irritations, pain or redness persists or worsens
• sore mouth symptoms do not improve in 7 days

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 and older			Swish one-half capful (2 tesapoons=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 SAFETY INFORMATION

Other Information

• cap tightly
• keep away from heat or direct sunlight
• do not use if safety seal is broken or missing

INACTIVE INGREDIENT

Inactive ingredients alcohol (4.1% by volume), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

QUESTIONS

Questions or comments call us at 1–800–952–5080 M–F 9am–5pm ET or visit our website atwww.orajel.com

Orajel Alcohol Free Antiseptic Rinse

#1

PAIN RELIEVER

BRAND FOR ADULTS

NOW WITH PAIN RELIEF!

Orajel

Antiseptic Rinse

FOR ALL MOUTH SORES

Canker Sores Cheek Bites Gum Irritation

Irritatrion from Dentures or Braces

Promotes Healing

Kills Bacteria

Provides Pain Relief

FRESH MINT

ORAL DEBRIDING AGENT / ANTISEPTIC RINSE / PAIN RELIEVER

16 FL OZ (473.2 mL)

Front Label OJLBF-32499-04.jpg

Back Label OJLBB-32499-04.jpg

INGREDIENTS AND APPEARANCE

ORAJEL ANTISEPTIC RINSE  FOR ALL MOUTH SORES
hydrogen peroxide 1.5%, menthol 0.1% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62864-760
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.5 mL  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLOXAMER 338 (UNII: F75JV2T505)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62864-760-16	473.2 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/01/2014

Labeler - Church & Dwight Canada Corp. (253933600)

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Canada Corp.		253933600	manufacture(62864-760)