DERMANUMB ANALGESIC- lidocaine hcl gel

DermaNumb Analgesic by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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

STOP USE

​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

​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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMANUMB ANALGESIC 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70188-006
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: 70188-006-01	57 g in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2015

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

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