HUSH 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.

----------

Hush Gel

Active Ingredients

Lidocaine HCL 4% w/w

Purpose

Pain Relieving Liquid

Keep out of reach of children

Uses

For the temporary relief of pain and itching associated with minor cuts or minor skin irritations

Directions

Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age; consult a physician.

Warnings

For external use only • Avoid contact with eyes

Stop use and ask a doctor if condition worsens or if symptoms persist more than 7 days or clear up and occur again with a few days

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

Other Information

Protect this product from excessive heat and direct sun.

Inactive ingredients

Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Calendula Officinale Extract, Caprylyl Glycol, Chamomile (Chamomile Recutita) Extract, Comfrey (Symphytum Officinale) Extract, Disodium EDTA, Glycerin, Green Tea (Camellia Sinensis) Extract, Menthol, Methylisothiazolinone, Propylene Glycol, SD Alcohol 40B, Triethanolamine

Questions or Comments?

Call 305-231-7229 or visit www.hushanesthetic.com

4oz label

2oz label

HUSH ANESTHETIC 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49947-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
COMFREY ROOT (UNII: M9VVZ08EKQ)  
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49947-002-04113.4 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2012
2NDC:49947-002-0256.7 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2012
Labeler - HUSH Anesthetic (012011309)

Revised: 1/2022
 
HUSH Anesthetic