FAMILY WELLNESS ANORECTAL LIDOCAINE- anorectal lidocaine cream

Family Wellness Anorectal Lidocaine by

Drug Labeling and Warnings

Family Wellness Anorectal Lidocaine by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR (Family Wellness). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active ingredient 

Lidocaine 5 % w/w

Purpose 

Local Anesthetic

Uses

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

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

If pregnant or breastfeeding,ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

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.

Other information 

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

Inactive ingredient

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

Questions 1-800-814-8028

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)

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS ANORECTAL LIDOCAINE 
anorectal lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-826
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHOLESTEROL (UNII: 97C5T2UQ7J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-826-28	1 in 1 CARTON	09/30/2023
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/30/2023

Labeler - FAMILY DOLLAR (Family Wellness) (024472631)