waxup numbing spray

waxup numbing spray
SPL v2
SPL
SPL Set ID 4f1645ab-1b19-4d69-99c3-9ea275b01a87
Route
topical
Published
Effective Date 2022-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
allantoin aloe vera leaf water benzyl alcohol carbomer homopolymer, unspecified type ethylhexylglycerin phenoxyethanol propylene glycol edetate sodium .alpha.-tocopherol acetate trolamine corn

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-12-23

Purpose

Anorectal (hemorrhoidal)

Description

Lidocaine HCL 5.00%


Medication Information

Purpose

Anorectal (hemorrhoidal)

Description

Lidocaine HCL 5.00%

Uses:
  • Helps relieve the local itching and discomfort in the perianal area
  • For the temporary relief of pain, irritation or burning.
Do Not:
  • exceed the recommended daily dosage unless directed by a doctor.
  • put this product into the rectum by using fingers or any mechanical device or applicator.
Warnings:

For external use only.

Drug Facts

Directions:

Adults:• When practical, cleanse the affected area "with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad. • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. • Children under 12 years of age: consult a doctor. • Apply externally to the affected area up to 6 times daily or after each bowel movement.

Package Labeling:

Active Ingredients

Lidocaine HCL 5.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Ethylhexylglycerin, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol.

When Using This Product:
  • If condition worsens or does not improve within 7 days, consult a doctor.
  • In case of bleeding, consult a doctor promptly.
Stop Use and Ask A Doctor If:
  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
  • Certain persons can develop allergic reactions to ingredients in this product.

Allergy alert: 

Keep Out of Raech of Children.

If swallowed, get medical help, or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding, 

ask a health professional before use.


Structured Label Content

Purpose

Anorectal (hemorrhoidal)

Uses:
  • Helps relieve the local itching and discomfort in the perianal area
  • For the temporary relief of pain, irritation or burning.
Do Not: (Do not:)
  • exceed the recommended daily dosage unless directed by a doctor.
  • put this product into the rectum by using fingers or any mechanical device or applicator.
Warnings:

For external use only.

Drug Facts

Directions:

Adults:• When practical, cleanse the affected area "with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad. • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. • Children under 12 years of age: consult a doctor. • Apply externally to the affected area up to 6 times daily or after each bowel movement.

Package Labeling:

Active Ingredients

Lidocaine HCL 5.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients: (Inactive ingredients:)

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Ethylhexylglycerin, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol.

When Using This Product: (When using this product:)
  • If condition worsens or does not improve within 7 days, consult a doctor.
  • In case of bleeding, consult a doctor promptly.
Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
  • Certain persons can develop allergic reactions to ingredients in this product.

Allergy alert: 

Keep Out of Raech of Children. (Keep out of raech of children.)

If swallowed, get medical help, or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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