HUSH Fast Acting Topical Anesthetic Gel

HUSH Fast Acting Topical Anesthetic by

Drug Labeling and Warnings

HUSH Fast Acting Topical Anesthetic by is a Otc medication manufactured, distributed, or labeled by Hush Anesthetic, Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HUSH FAST ACTING TOPICAL ANESTHETIC- lidocaine gel 
Hush Anesthetic

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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HUSH Fast Acting Topical Anesthetic Gel

HUSH Fast Acting Topical Anesthetic Gel


Drug Facts


Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses:

For the temporary relief of discomfort and pain associated with

  • minor burns and skin irritations
  • minor cuts and scrapes
  • itching

Warnings:

For external use only.

Avoid contact with eyes.


Do not use In large quantities, particularly over raw surfaces or blistered areas


Stop use and ask a doctor if

  • skin becomes irritated
  • condition worsens or symptoms last more than 7 days
  • symptoms clear up and reoccur within a few days

Keep out of reach of children


Directions

Adults and children 12 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Other Ingredients:

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

HUSH Fast Acting Topical Anesthetic Gel 2oz/60g

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HUSH FAST ACTING TOPICAL ANESTHETIC 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49947-909
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
COMFREY LEAF (UNII: DG4F8T839X)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49947-909-0260 g in 1 BOTTLE; Type 0: Not a Combination Product04/04/201212/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/04/201212/31/2019
Labeler - Hush Anesthetic (012011309)
Registrant - Filltech USA, LLC (965596435)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC926433855manufacture(49947-909)

Revised: 11/2019
Document Id: 982faa74-d481-cd1e-e053-2995a90afa1e
Set id: 2bf398a5-d4c0-4d1f-b3b6-2c583bfe79cc
Version: 3
Effective Time: 20191125
 
Hush Anesthetic