DermaNumb Tattoo Anesthetic Gel

DermaNumb Tattoo Anesthetic Gel

Drug Labeling and Warnings

Drug Details

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DERMANUMB ANESTHETIC GEL- lidocaine hcl gel 
A.T.S. Laboratories, LLC

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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DermaNumb Tattoo Anesthetic Gel

Active Ingredients

Lidocaine HCL 4.0% w/w

Purpose

External Analgesic

Uses

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

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 doctor if

​ Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again with a few days.  Discontinue use.

​Keep out of reach of children

If product is swallowed, get medical help or contact a poison control center right away.

Directions

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

Inactive Ingredients

Achillea Millegolium (Yarrow) Extract, Alcohol SDA-40, Aloe Barbadensis Leaf Extract, Capryly Glycol, Carbomer, Disodium EDTA, Glycerin, Menthol, Methylisothiazolinone, Propylene Glycol, Schidigera (Yucca) Root Extract, Triethanolamine, Water.

Other Information

Protect this product from excessive heat and direct sun.

Questions or Comments?

954-492-9898

Label

DERMANUMB ANESTHETIC GEL 
lidocaine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70188-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE40 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)  
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
MENTHOL (UNII: L7T10EIP3A)  
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70188-004-0157 g in 1 PACKAGE; Type 0: Not a Combination Product07/01/201511/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/201511/26/2019
Labeler - A.T.S. Laboratories, LLC (080013331)

Revised: 11/2019
 
A.T.S. Laboratories, LLC


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