NUMPOT TOPICAL ANESTHETIC- lidocaine, petrolatum ointment

Numpot Topical Anesthetic by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

Lidocaine 5%

Petrolatum 71%

PURPOSE

Anesthetic

Skin Protectant

USES:

Temporarily relieves local discomfort, pain and Swelling, or burning associated with anorectal disorders.

WARNING:

External use only. Keep out of eyes. Allergic reactions can occur.

STOP USE & ASK A DOCTOR:

If condition worsens or does not improve within 7 days

• If redness, irritation, pain, swelling or other symptoms develop or increase
• If bleeding occurs.

KEEP OUT OF REACH OF CHILDREN:

If swallowed get medical help or contact a Poison Control Center ASAP.

DIRECTIONS:

Apply sparingly to affected area as often as needed up to 6 times daily.

​STORE IN COOL DARK AREA.

INACTIVE INGREDIENTS:

Mineral Oil, Lanolin Alcohol, Polysorbate 60, Paraffin, Sorbitan Oleate, Tocopheryl Acetate (Vit. E Acetate), Aloe Barbadensis (Organic Aloe Vera) leaf juice, Cholecalciferol (Vit. D3), Phytonadione (Vit. K1)

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Package Labeling:

INGREDIENTS AND APPEARANCE

NUMPOT TOPICAL ANESTHETIC 
lidocaine, petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67194-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	710 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PARAFFIN (UNII: I9O0E3H2ZE)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
PHYTONADIONE (UNII: A034SE7857)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67194-018-01	28 g in 1 JAR; Type 0: Not a Combination Product	01/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/20/2016

Labeler - Unit Dose, Ltd. (119080393)

Establishment
Name	Address	ID/FEI	Business Operations
Unit Dose, Ltd.		119080393	relabel(67194-018)