numstick

numstick
SPL v4
SPL
SPL Set ID 127bbd87-5402-4da2-abf3-dac6367735ec
Route
topical
Published
Effective Date 2016-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (600 mg) lidocaine (50 mg)
Inactive Ingredients
jojoba oil lanolin yellow wax ceresin candelilla wax paraffin diethylene glycol monoethyl ether menthol .alpha.-tocopherol acetate cholecalciferol vitamin a palmitate phytonadione

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-01-22

Description

Petrolatum (White) 60% Lidocaine 5.0%


Medication Information

Description

Petrolatum (White) 60% Lidocaine 5.0%

Uses:

Temporary relief of anorectal discomfort

Section 55105-1

Skin Protectant

External or Topical Analgesic

Warning:

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

Directions:

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

Do Not Use:

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

Ingredients:

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

Package Labeling:

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.

Active Ingredient in Each Gram

Petrolatum (White) 60%

Lidocaine 5.0%


Structured Label Content

Uses: (USES:)

Temporary relief of anorectal discomfort

Section 55105-1 (55105-1)

Skin Protectant

External or Topical Analgesic

Warning: (WARNING:)

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

Directions: (DIRECTIONS:)

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

Do Not Use:

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

Ingredients: (INGREDIENTS:)

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

Package Labeling:

Stop Use and Ask A Doctor: (STOP USE AND ASK A DOCTOR:)

if pain worsens, or bleeding or swelling occurs

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

and get medical help right away if swallowed.

Active Ingredient in Each Gram (Active Ingredient in each Gram)

Petrolatum (White) 60%

Lidocaine 5.0%


Advanced Ingredient Data


Raw Label Data

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