ANESGERM- benzocaine gel 
World Perfumes, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient                                       Purpose

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

Uses

for the temporary relief of pain due to:

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

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:

Children under 2 years of age:

Teething Infants 4 months of age and over:

Infants under 4 months of age:

GERMA

Anesterm

Maximum Strength Oral Pain Reliever

20% Benzocaine PLUS Oil of Cloves

Fast Pain Relief

Easy To Apply

Warnings

Do not exceed recommended dosage.

Do not use

Stop use and ask a doctor if

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

Inactive Ingredients

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

label image

ANESGERM 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10095-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10095-001-010.5 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/30/2015
Labeler - World Perfumes, Inc (101312044)
Establishment
NameAddressID/FEIBusiness Operations
World Perfumes, Inc101312044manufacture(10095-001)

Revised: 5/2015
Document Id: 898632e8-9d4e-4a68-a5c7-ec62e33ca6ff
Set id: 982e6c46-37ab-419b-acea-521b3c356a7c
Version: 2
Effective Time: 20150508
 
World Perfumes, Inc