BENZOCAINE, MENTHOL, ZINC CHLORIDE- orajel severe pm toothache and gum relief cream

Benzocaine, Menthol, Zinc Chloride by

Drug Labeling and Warnings

Benzocaine, Menthol, Zinc Chloride by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 20%

Menthol 0.25%

Zinc Chloride 0.15%

PURPOSE

Use for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums

WARNINGS

Warnings

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

DO NOT USE

Do not use more than directed for more than 7 days unless directed by a physician or healthcare provider

STOP USE

Stop use and ask a physician if swelling, rash or fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days allergic reaction occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions cut open tip of tube on score mark

Adults and children 2 years of age and over - Apply a small amount of product to the affected area, use up to 4 times daily or as directed by a physician or healthcare provider

Children under 12 years of age - Should be supervised in the use of this product

Children under 2 years of age - Ask a physician or healthcare provider

Other Information do not use if tube tip is cut prior to opening do not use continuously Cream will stay in place for extended duration of relief.

INACTIVE INGREDIENT

cellulose gum, chamomile, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin

QUESTIONS

Question or comments call us at 800 952 5080 Monday through Friday 9-5 or visit www orajel com

INDICATIONS & USAGE

Use for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums

PRINCIPAL DISPLAY PANEL

#1

Oral Pain

Reliever Brand

For Toothache

New Formula!

3x More

Acitve Ingredients*

Orajel

Instant Pain Relief

Severe PM

Toothache & Gum Relief Plus

Triple Medicated

Nighttime Formula with Chamomile

20% Benzocaine to Relieve Oral Pain

Astringent to Relieve Gum Irritation NEW

Menthol to Soothe Gums

Oral Pain Reliever/Astringent NET WT 0.25 OZ. (7.0 g)

Long-Lasting

Cream

OJFC-31854-10 (2).jpg

INGREDIENTS AND APPEARANCE

BENZOCAINE, MENTHOL, ZINC CHLORIDE 
orajel severe pm toothache and gum relief cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-771
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.5 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CHAMOMILE (UNII: FGL3685T2X)
GELATIN (UNII: 2G86QN327L)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MINERAL OIL (UNII: T5L8T28FGP)
PECTIN (UNII: 89NA02M4RX)
PETROLATUM (UNII: 4T6H12BN9U)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-771-25	1 in 1 CARTON	04/27/2017	12/17/2021
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/27/2017	12/17/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-771)