RITE AID SEVERE TOOTHACHE AND GUM RELIEF TRIPLE MEDICATED- benzocaine, menthol, zinc chloride gel

Rite Aid Severe Toothache and Gum Relief by

Drug Labeling and Warnings

Rite Aid Severe Toothache and Gum Relief by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients

Benzocaine 20%

Menthol 0.5%

Zinc Chloride 0.15%

PURPOSE

Purpose

Oral pain reliever

Oral pain reliever

Astringent

INDICATIONS & USAGE

Use

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

WARNINGS

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

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

• more than directed
• for more than 7 days unless directed by a dentist or doctor
• for teething
• in children under 2 years of age

Stop use and ask a doctor if

• swelling, reash 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. In case of overdose, 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 the product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor.
• children between 2 and 12 years of age should be supervised in the use of this product
• children under 2 years of age: do not use

OTHER SAFETY INFORMATION

Other information

• do not use if tip is cut prior to opening
• this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
• do not use continuously
• this formula will stay in place for extended duration of relief
• avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

INACTIVE INGREDIENT

Inactive ingredientsblue 1, cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin

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DISTRIBUTED BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL

RITE AID® PHARMACY

SEVERE

toothache & gum relief

immediate relief of intense pain

fast acting GEL

ORAL PAIN RELIEVER / ASTRINGENT

triple medicated

• 20% Benzocainefor toothache pain relief
• Astringent to relieve gum irritation
• Menthol to soothe gums

NET WT 0.25 OZ (7.0 g)

INGREDIENTS AND APPEARANCE

RITE AID SEVERE TOOTHACHE AND GUM RELIEF  TRIPLE MEDICATED
benzocaine, menthol, zinc chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-6038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.15 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
PECTIN (UNII: 89NA02M4RX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYL SALICYLATE (UNII: LAV5U5022Y)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-6038-9	1 in 1 CARTON	03/04/2019
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	03/04/2019

Labeler - Rite Aid (014578892)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(11822-6038)