DermaNumb Tattoo Anesthetic Gel

DermaNumb Tattoo Anesthetic Gel by

Drug Labeling and Warnings

DermaNumb Tattoo Anesthetic Gel by is a Otc medication manufactured, distributed, or labeled by A.T.S. Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DERMANUMB TATTOO 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

DERMANUMB TATTOO ANESTHETIC GEL 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70188-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70188-002-02	57 g in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2015	01/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2015	01/17/2018

Labeler - A.T.S. Laboratories, LLC (080013331)

Revised: 1/2018

Document Id: 4f2f0d24-1701-4a72-a37c-96a4fb0f0aaa

34390-5

Set id: 76ae255d-03e3-4c13-8d12-e430bbaac957

Version: 3

Effective Time: 20180117

 

A.T.S. Laboratories, LLC