DERMANUMB TATTOO ANESTHETIC- 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 Spray

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, Caprylyl Glycol, Citric Acid, Disodium EDTA, Methylisothiazolinone, Propylene Glycol, Schidigera (Yucca) Root Extract, Sodium Metabisulfate, Water.

Other Information

Protect this product from excessive heat and direct sun.

Questions or Comments?

954-492-9898

1oz Label

4oz Label

DERMANUMB TATTOO ANESTHETIC
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70188-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70188-001-01	28 g in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2015	01/12/2018
2	NDC:70188-001-04	113 g in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2015	01/12/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/01/2015	01/12/2018

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

Revised: 12/2019

Document Id: cb613c50-28fd-43d8-9a6c-4736027e79e5

Set id: 88937f01-9fd4-41e7-a96a-3bdd7215f095

Version: 4

Effective Time: 20191204

A.T.S. Laboratories, LLC