FDA Label for Anesgerm
View Indications, Usage & Precautions
Anesgerm Product Label
The following document was submitted to the FDA by the labeler of this product World Perfumes, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient Purpose
Benzocaine 20% .................................... Pain Reliever
Otc - 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
Otc - 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
- consult a dentist or doctor
- apply to the affected area up to 4 times daily or as directed by a dentist or doctor
- consult a dentist or doctor
Children under 2 years of age:
Teething Infants 4 months of age and over:
Infants under 4 months of age:
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
- 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
Stop use and ask a doctor if
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
Package Label.Principal Display Panel
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