DENTAL RELIEF- benzocaine liquid

Dental Relief by

Drug Labeling and Warnings

Dental Relief by is a Otc medication manufactured, distributed, or labeled by Cintas First Aid & Safety, Safetec of America, Inc., Safetec Of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Dental Relief

Active Ingredients

Benzocaine 20% (w/w)

Purpose

Oral antiseptic

Uses

For temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

Warnings

For oral use only

Allergy alert

Do not use this product if you have a history of allergy to local anaesthetics, such as procaine, butacaine, benzocaine, or other “caine” anaesthetics due to the possibility of anaphylactic shock.

When using this product

Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

Keep out of reach of children.

If more than used for pain relief and protection is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 2 years and older: dry affected area and apply medication undiluted; Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor
• Consult a dentist or doctor for use on children under 2 years of age
• Children under 12 years of should be supervised in the use of this product

Other information

• Do not use if packet is torn, cut or opened
• Store at room temperature, 15° to 30°C (59° to 86°F)
• Avoid contact with eyes

Inactive Ingredients

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

Principal Display Panel – 0.5 gram Packet

Dental Relief

Active ingredients: Benzocaine (20%), Compound benzoin tincture

USES: Temporarily relieves pain due to canker sores, minor irritation of
the mouth and gums caused by dentures or orthodontic appliances,
or minor mouth and gum injuries.

Do not use if packet is torn or broken

NET WT 0.5g

Principal Display Panel – Pocket Card

Dental Relief

PROFESSIONAL STRENGTH
RELIEVES DENTAL PAIN

COMPARE TO ORAJEL

SEE DRUG FACTS CARD
FOR COMPLETE WARNINGS

560718
12/13

Xpect
First aid

INGREDIENTS AND APPEARANCE

DENTAL RELIEF 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68421-8100
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

Inactive Ingredients
Ingredient Name	Strength
polyethylene glycol 400 (UNII: B697894SGQ)
polyethylene glycol 3350 (UNII: G2M7P15E5P)
peppermint oil (UNII: AV092KU4JH)
saccharin sodium (UNII: SB8ZUX40TY)
sorbic acid (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68421-8100-3	10 in 1 BAG	05/06/2016
1	NDC: 68421-8100-2	0.5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 68421-8100-4	500 in 1 BOX	05/06/2016
2	NDC: 68421-8100-2	0.5 g in 1 PACKET; 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	05/06/2016

Labeler - Cintas First Aid & Safety (056481716)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec Of America, Inc.		874965262	MANUFACTURE(68421-8100)