ANESGERM- benzocaine gel

Anesgerm by

Drug Labeling and Warnings

Anesgerm by is a Otc medication manufactured, distributed, or labeled by Caribe Natural, Inc, World Perfumes, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                       Purpose

Benzocaine 20% .................................... Pain Reliever

PURPOSE

Uses

for the temporary relief of pain due to:

• toothache
• minor irritation or injury of the mouth and gums
• infection cause by dentures or orthodontic appliances
• sore gums due to teething in infants and children 4 months of age and older

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help immediately.

DOSAGE & ADMINISTRATION

Directions

children under 12 years of age should be supervised in the use of this product.  Adults and children 12 years of age and older:

• apply to the affected area up to 4 times a day or as directed by a dentist or doctor

Children under 2 years of age:

• consult a dentist or doctor

Teething Infants 4 months of age and over:

• apply to the affected area up to 4 times daily or as directed by a dentist or doctor

Infants under 4 months of age:

• consult a dentist or doctor

INDICATIONS & USAGE

GERMA

Anesterm

Maximum Strength Oral Pain Reliever

20% Benzocaine PLUS Oil of Cloves

Fast Pain Relief

Easy To Apply

• Toothache
• Sore Gums
• Teething
• Denture Irritation
• Braces Irritation

WARNINGS

Warnings

Do not exceed recommended dosage.

Do not use

• for more than 7 days unless directed by a dentist or doctor
• if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

Stop use and ask a doctor if

• sore mouth symptoms do not improve in 7 days
• infection, pain, or redness persists or worsens
• swelling, rash or fever develops
• fever & nasal congestion are present in teething infants 4 months of age and over

These symptoms may be a sign of infection or a serious condition.

INACTIVE INGREDIENT

Inactive Ingredients

polyethylene glycol-75, polyethylene glycol-8, glycerin, propyl paraben, methyl paraben, sodium saccharin, clove oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANESGERM 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59561-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CLOVE OIL (UNII: 578389D6D0)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59561-001-01	0.5 g in 1 PACKAGE; 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	04/30/2015

Labeler - Caribe Natural, Inc (624210480)

Establishment
Name	Address	ID/FEI	Business Operations
World Perfumes, Inc		101312044	manufacture(59561-001)