rugby lidocaine cream

rugby lidocaine cream
SPL v2
SPL
SPL Set ID d94292f7-10fc-48bf-e053-2995a90a8472
Route
topical
Published
Effective Date 2022-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
light mineral oil propylparaben anhydrous citric acid white petrolatum propylene glycol water methylparaben butylated hydroxytoluene cetostearyl alcohol polyoxyl 20 cetostearyl ether sodium citrate edetate disodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-03-02

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

For external use only.

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, or symptoms clear up and return within a few days.

Active Ingredient

Lidocaine 4%

Uses

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Dosage and Administration
  • When practical, cleanse the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.
Description

Lidocaine 4%

Section 50565-1

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Butylated Hydroxytoluene, Cetostearyl Alcohol, Citric Acid, Edetate Disodium, Light Mineral Oil, Methylparaben, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, White Petrolatum.

Section 51945-4

Section 53414-9

If pregnant or breastfeeding, ask a professional before use.

Section 55105-1

Local Anesthetic


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, or symptoms clear up and return within a few days.

Active Ingredient (55106-9)

Lidocaine 4%

Uses

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Dosage and Administration (34068-7)
  • When practical, cleanse the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.
Section 50565-1 (50565-1)

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Butylated Hydroxytoluene, Cetostearyl Alcohol, Citric Acid, Edetate Disodium, Light Mineral Oil, Methylparaben, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, White Petrolatum.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a professional before use.

Section 55105-1 (55105-1)

Local Anesthetic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)