ORAJEL 2X GUM PAIN ALCOHOL-FREE- menthol and hydrogen peroxide rinse

Orajel 2x Gum Pain by

Drug Labeling and Warnings

Orajel 2x Gum Pain 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Hydrogen peroxide 1.5%	Oral debriding agent/Oral antiseptic
Menthol 0.1%	Oral pain reliever

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

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

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 = 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

disodium EDTA, FD&C blue no.1, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 473.2 mL Bottle Label

1#
ORAL PAIN
RELIEF BRAND
FOR ADULTS

Orajel™
2X
GUM PAIN RINSE
MEDICATED
ALCOHOL FREE

EFFECTIVE ORAL PAIN RELIEF

• ✓ Soothes & Cools Gums
• ✓ Kills Harmful Bacteria
• ✓ Promotes Healing
• ✓ Relieves Gum Irritation
  Caused by Dentures or Braces

ORAL DEBRIDING AGENT/
ANTISEPTIC RINSE/PAIN RELIEVER

Soothing
MINT

16 FL OZ (473.2 mL)

OJLBF-01904-01 72025286

INGREDIENTS AND APPEARANCE

ORAJEL 2X GUM PAIN   ALCOHOL-FREE
menthol and hydrogen peroxide rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-799
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol, unspecified form (UNII: L7T10EIP3A) (Menthol, unspecified form - UNII:L7T10EIP3A)	Menthol, unspecified form	1 mg  in 1 mL
Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V)	Hydrogen Peroxide	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
Methyl Salicylate (UNII: LAV5U5022Y)
Phosphoric Acid (UNII: E4GA8884NN)
Poloxamer 338 (UNII: F75JV2T505)
Polysorbate 20 (UNII: 7T1F30V5YH)
Propylene Glycol (UNII: 6DC9Q167V3)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-799-16	473.2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/15/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Canada Corp.		253933600	MANUFACTURE(10237-799)