NUMSTICK- petrolatum, lidocaine stick

Numstick by

Drug Labeling and Warnings

Numstick by is a Otc medication manufactured, distributed, or labeled by Unit Dose, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient in each Gram

Petrolatum (White) 60%

Lidocaine 5.0%

Skin Protectant

External or Topical Analgesic

USES:

Temporary relief of anorectal discomfort

WARNING:

External Use Only. Keep out of eyes.. You may develop allergic reaction to ingredients.

Do Not Use:

More than directed or in the rectum with any mechanical device or applicator.

STOP USE AND ASK A DOCTOR:

if pain worsens, or bleeding or swelling occurs

KEEP OUT OF REACH OF CHILDREN

and get medical help right away if swallowed.

DIRECTIONS:

Apply .5-1.0 gm. to desired clean dry area up to 4 times/day as needed.

INGREDIENTS:

Simmondisa Chinensis (Jojoba) Seed oil, Lanolin, Beeswax, Ozokerite wax, Candelilla wax, Paraffin, Ethoxydiglycol, Menthol, Tocopheryl Acetate, Cholecalciferol, Retinyl Palmitate, Phytonadione

Package Labeling:

INGREDIENTS AND APPEARANCE

NUMSTICK 
petrolatum, lidocaine stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67194-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	600 mg  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL (UNII: 724GKU717M)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
PARAFFIN (UNII: I9O0E3H2ZE)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
MENTHOL (UNII: L7T10EIP3A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PHYTONADIONE (UNII: A034SE7857)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67194-014-01	4 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/22/2016

Labeler - Unit Dose, Ltd. (119080393)

Establishment
Name	Address	ID/FEI	Business Operations
Unit Dose, Ltd.		119080393	relabel(67194-014)