FEEL BETTER NOW- lidocaine cream
Clinical Resolution Laboratory, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Feel Better Now

Drug Facts

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses

for the temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation.

Warning

For External use only

Do not use this product if:

Pregnant or breast-feeding, ask a health professional before use.
In case of accidental overdose, contact a doctor or Poison Control Center immediately
Tamper Evident "Warranty Void.. Seal.. label atop the container is broken.

When using this product:

Do not exceed the recommended 6 times a day.
In rare cases allergic reactions to ingredients in this product may occur.
Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Keep out of eyes.

Stop use and ask a doctor if:

the symptom being treated does not subside or if redness, irritation, swrlling, pain or other symptoms develop or increases.

Keep out of reach of children.

In case of accidental ingestion, seek medical attention immediately.

Other Information

Keep away from direct sunlight or heat
Store in room temperature (59-86 oF / 15-30 oC)

Directions:

Adults: When practical, Cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry before application of this product.
Apply to small area for 15 to 25 minutes
Children under 12 years of age: consult a doctor

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Triethanolamine, Carbomer, Ethoxydiglycol, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Sodium Polyacrylate, Hydrogenated Polycene, Trideceth-10, Cholesterol Allantoin, Tocopheryl Acetate, Bisabolo

Package Labeling

Label

FEEL BETTER NOW
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63742-005
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
TRIDECETH-10 (UNII: G624N6MSBA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63742-005-00	15 g in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2018	03/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	03/01/2018	03/01/2018

Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Revised: 12/2022

Document Id: f0d54306-84dc-5dbf-e053-2995a90afdb0

Set id: 5bc3e0a8-e793-4618-98e9-8caa67274f77

Version: 5

Effective Time: 20221227

Clinical Resolution Laboratory, Inc.