RETALIEF LIDOCAINE 5- lidocaine cream

RETALIEF LIDOCAINE 5 by

Drug Labeling and Warnings

RETALIEF LIDOCAINE 5 by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 5% W/W

PURPOSE

Local Anesthetic Anorectal (Hemorrhoidal) Cream

INDICATIONS & USAGE

helps relieve the pain, itching, and burning, associated with hemorrhoids and anorectal disorders

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING

When using this product

• avoid contact with eyes
• do not use more than directed unless directed by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator

STOP USE

Stop use and ask a doctor if

• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• an allergic reaction occurs
• symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
• symptoms clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, 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, cleanse the affected 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 of age and older: apply externally to the affected area not more than 6 times a day.
• children under 12 years of age: consult a doctor.

OTHER SAFETY INFORMATION

Store between 20°-25° C (68°-77° F)

INACTIVE INGREDIENT

Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cholesterol, Isopropyl myristate, Mineral Oil, Polysorbate 80, Propylene Glycol, Purified Water, Tocopherol, Trolamine.

PRINCIPAL DISPLAY PANEL

NDC: 69618-075-78

Reliable 1 Laboratories

Rectalief

Anorectal Cream

Lidocaine 5%

Relieves Pain, Itching & Burning

Highest Strength of Non-Rx Lidocaine Available

1OZ (30gm)

QUESTIONS

1-516-341-0666 Monday- Friday

Distributed by

Reliable 1 Labs

99 W. Hawthorne Ave #610

Valley Stream, NY 11580

www.reliable1labs.com

Made in China

INGREDIENTS AND APPEARANCE

RETALIEF LIDOCAINE 5 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
CARBOMER (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-075-78	1 in 1 CARTON	01/20/2025
1		30 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	01/20/2025

Labeler - Reliable 1 Laboratories LLC (079718111)