ORAJEL ANTISEPTIC RINSE FOR MOUTH SORES- hydrogen peroxide liquid

Orajel Antiseptic Rinse for Mouth Sores by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Active ingredient

hydrogen peroxide 1.5%

Purpose

Oral debriding agent

Uses

for temporary use in cleansing minor wounds or minor gum inflammation resulting from:

• minor dental procedures
• orthodontic appliances
• dentures
• accidental injury
• canker sores
• other irritations of the mouth and gums

Aids in the removal of:

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

Warnings

Do not use this product for more than 7 days unless directed by a dentist or doctor

When using this product do not swallow

Stop use

Stop use and see your dentist or doctor promptly if

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

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 and older

• Swish one-half capful (2 teaspoons = 10 mL) 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 doctor

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 doctor

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 EDTA, methylparaben, methyl salicylate, phosphoric acid, poloxamer 338, purified water, sodium saccharin, sorbitol

Questions or comments?

call us at 1-800-952-5080 M-F 9am - 5pm ETor visit our website at www.orajel.com

PRINCIPAL DISPLAY PANEL

#1 ORAL PAIN

RELIEVER BRAND

FOR ADULTS

With

PAIN RELIEF!

Orajel

FOR ALL MOUTH SORES

ANTISEPTIC RINSE

Canker Sores Cheek Bites Gum Irritation

Irritation from Dentures or Braces

Promotes Healing

Kills Bacteria

Provides Pain Relief

ORAL DEBRIDING AGENT/

ANTISEPTIC RINSE/PAIN RELIEVER

16 FL OZ (473.2 mL)

INGREDIENTS AND APPEARANCE

ORAJEL ANTISEPTIC RINSE FOR MOUTH SORES 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-793
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	0.015 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-793-16	473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/29/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/29/2010

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Canada Corp.		253933600	manufacture(10237-793)