Numb520 Spray

Numb520 Spray
SPL v5
SPL
SPL Set ID 26d74a03-98c6-4e99-a657-bfdd1b3dbf38
Route
TOPICAL
Published
Effective Date 2018-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Cholesterol Sodium Metabisulfite Polysorbate 80 Phenoxyethanol Edetate Disodium Anhydrous Water Aloe Vera Leaf Propylene Glycol Benzyl Alcohol Epinephrine Hydrochloride Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-15

Description

Lidocaine 5%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5%

Uses:

Temporarily relieves pain, itching, or swelling associated with anorectal disorders.

Warnings

(For external use only)

Directions
  • Sensitivity test advised prior to use. Apply sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs (90 seconds). You may reapply to continue numbing effect.
  • Apply up to 6 times a day.
  • Children under 12 year of age: consult a doctor.
Active Ingredient

Lidocaine 5%

Other Information
  • Keep away from direct sunlight or heat.
  • Store in room temperature (59-86°F / 15-30°C).
Package Labeling:

Inactive Ingredients

Water, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propylene Glycol, Benzyl Alcohol, Epinephrine HCL, Citric Acid, Disodium EDTA, Cholesterol, Sodium Metabisulfite, Lecithin, Polysorbate 80, Phenoxyethanol

When Using This Product
  • Do not exceed the recommended daily unless directed by a doctor.
  • Certain persons can develop allergic reactions to ingredients in this product.
  • Do not put this product into the rectum by using fingers or any medical device or applicator.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately. 
Do Not Use This Product If
  • Pregnant or breastfeeding, ask a health professional before use
  • Tamper-evident shrink band around the container is broken.
Stop Use and Ask A Doctor If

The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep Out of Reach of Children

In case of accidental ingestion, seek medical attention immediately.


Structured Label Content

Uses:

Temporarily relieves pain, itching, or swelling associated with anorectal disorders.

Purpose

Local Anesthetic

Warnings

(For external use only)

Directions
  • Sensitivity test advised prior to use. Apply sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs (90 seconds). You may reapply to continue numbing effect.
  • Apply up to 6 times a day.
  • Children under 12 year of age: consult a doctor.
Active Ingredient

Lidocaine 5%

Other Information
  • Keep away from direct sunlight or heat.
  • Store in room temperature (59-86°F / 15-30°C).
Package Labeling:

Inactive Ingredients

Water, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propylene Glycol, Benzyl Alcohol, Epinephrine HCL, Citric Acid, Disodium EDTA, Cholesterol, Sodium Metabisulfite, Lecithin, Polysorbate 80, Phenoxyethanol

When Using This Product (When using this product)
  • Do not exceed the recommended daily unless directed by a doctor.
  • Certain persons can develop allergic reactions to ingredients in this product.
  • Do not put this product into the rectum by using fingers or any medical device or applicator.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately. 
Do Not Use This Product If (Do not use this product if)
  • Pregnant or breastfeeding, ask a health professional before use
  • Tamper-evident shrink band around the container is broken.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, seek medical attention immediately.


Advanced Ingredient Data


Raw Label Data

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