BENZOCAINE, MENTHOL, ZINC CHLORIDE- orajel instant pain relief severe gel

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 0.5%

Zinc Chloride 0.15%

PURPOSE

Benzocaine - Oral pain reliever

Menthol - Oral pain reliever

Zinc Chloride - Oral astringent

INDICATIONS & USAGE

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, 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 older - 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 Gel will stay in place for extended duration of relief

INACTIVE INGREDIENT

blue 1, cellulose gum. gelatin, methyl saliclate, mineral oil, pectin, petrolatum, polyethylen glycol, sodium saccharin

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

#1

Oral Pain

Reliver Brand

For Toothache

New Formula!

3X More

Active Ingredients*

Orajel™

Instant Pain Relief

Severe

Toothache & Gum Relief Plus

Triple Medicated

20% Benzocaine to Relieve Oral Pain

Astringent to Relieve Gum Irritation

Menthol to Soothe Gums

Safety Sealed

Tube Tip

Fast Acting Gel

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

INGREDIENTS AND APPEARANCE

BENZOCAINE, MENTHOL, ZINC CHLORIDE 
orajel instant pain relief severe gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-769
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	2.5 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GELATIN (UNII: 2G86QN327L)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MINERAL OIL (UNII: T5L8T28FGP)
PECTIN (UNII: 89NA02M4RX)
PETROLATUM (UNII: 4T6H12BN9U)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-769-25	1 in 1 CARTON	04/26/2017	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	04/26/2017	12/17/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-769)