numpot topical anesthetic balm

numpot topical anesthetic balm
SPL v4
SPL
SPL Set ID 9143b50b-7d76-4545-aa2e-1bb77ffb44ae
Route
topical
Published
Effective Date 2016-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (50 mg) petrolatum (710 mg)
Inactive Ingredients
mineral oil lanolin alcohols polysorbate 60 paraffin sorbitan monooleate .alpha.-tocopherol acetate aloe vera leaf cholecalciferol phytonadione

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-01-20

Purpose

Anesthetic Skin Protectant

Description

Lidocaine 5% Petrolatum 71%


Medication Information

Purpose

Anesthetic

Skin Protectant

Description

Lidocaine 5% Petrolatum 71%

Questions?

Call us at Toll Free (888)664-9990

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.

Drug Facts

Directions:

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

​STORE IN COOL DARK AREA.

Package Labeling:

Active Ingredients

Lidocaine 5%

Petrolatum 71%

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)

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.


Structured Label Content

Purpose (PURPOSE)

Anesthetic

Skin Protectant

Questions?

Call us at Toll Free (888)664-9990

Uses: (USES:)

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

Warning: (WARNING:)

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

Drug Facts (DRUG FACTS)

Directions: (DIRECTIONS:)

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

​STORE IN COOL DARK AREA.

Package Labeling:

Active Ingredients (ACTIVE INGREDIENTS)

Lidocaine 5%

Petrolatum 71%

Inactive Ingredients: (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)

Stop Use & Ask A Doctor: (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: (KEEP OUT OF REACH OF CHILDREN:)

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


Advanced Ingredient Data


Raw Label Data

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