Family Wellness anorectal Lidocaine Cream 

Family Wellness anorectal Lidocaine Cream 
SPL v3
SPL
SPL Set ID ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d
Route
TOPICAL
Published
Effective Date 2023-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Propylene Glycol Hydrogenated Soybean Lecithin Trolamine Isopropyl Myristate Benzyl Alcohol Carbomer Homopolymer, Unspecified Type Polysorbate 80 .alpha.-tocopherol Acetate Cholesterol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-30

Description

Lidocaine 5 % w/w

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5 % w/w

Uses

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

Section 50565-1

Keep out of reach of children.

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

Purpose 

Local Anesthetic

Warnings 

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
  • symptoms clear up and return within a few days

Directions 
  • When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or 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.
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.
Active Ingredient 

Lidocaine 5 % w/w

Inactive Ingredient

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate

Other Information 

Store at controlled room temperature 68-77° F (20-25 °C)

Questions 1 800 814 8028

If Pregnant Or Breastfeeding,

Principal Display Panel Tube 

Family Wellness         NDC 55319-826-28

HEMORRHOIDAL CREAM 

Lidocaine 5%

NET WT 1 OZ (28.3g)

Principal Display Panel Carton 

Family Wellness NDC 55319-826-28

HEMORRHOIDAL CREAM

Lidocaine 5%

NET WT 1 OZ (28.3g)


Structured Label Content

Uses

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

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Purpose 

Local Anesthetic

Warnings 

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
  • symptoms clear up and return within a few days

Directions 
  • When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or 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.
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.
Active Ingredient  (Active ingredient )

Lidocaine 5 % w/w

Inactive Ingredient (Inactive ingredient)

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate

Other Information  (Other information )

Store at controlled room temperature 68-77° F (20-25 °C)

Questions 1 800 814 8028 (Questions 1-800-814-8028)

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

Principal Display Panel Tube  (Principal display panel -Tube )

Family Wellness         NDC 55319-826-28

HEMORRHOIDAL CREAM 

Lidocaine 5%

NET WT 1 OZ (28.3g)

Principal Display Panel Carton  (Principal Display Panel -Carton )

Family Wellness NDC 55319-826-28

HEMORRHOIDAL CREAM

Lidocaine 5%

NET WT 1 OZ (28.3g)


Advanced Ingredient Data


Raw Label Data

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