PAIN RELIEVING CREAM LIDOCAINE- benzyl alcohol, lidocaine hci cream

Pain Relieving Cream Lidocaine by

Drug Labeling and Warnings

Pain Relieving Cream Lidocaine by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Anasthetic

ACTIVE INGREDIENT

Benzyl Alcohol 10%

Purpose

Topical Anesthetic

Uses

Temporary Pain Relief

Do Not Use

• On wounds or damaged skin
• In large quantities
• With a heating pad
• if you are allergic to any ingredients of this product

When Using this Product

• Use only as direcgted
• Avoid contact with eyes, mucous membranes or rashes
• Do not bandage tightly

Warnings

For external Use Only

Do not use

• in eyes
• in large quantities
• over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
• for more than one week unless directed by a doctor

If Pregnant or Breast Feeding

Ask a health professional before use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away

Directions

Adults and children over 12 years

• clean and dry affected area
• Apply to affected area not more than 3 to 4 times daily

Children 12 years or younger

• ask a doctor

Stop Use and Ask a Doctor If

• Skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Conditions worsen
• Symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days

Other Information

• Avoid storing product in direct sunlight
• Protect product from excessive moisture
• Store with lid closed tightly

Inactive Ingredients

Aloe barbadensis leaf juice, aminomethyl propanol, Butylene glycol, carbome interpolymer type A (allyl sucrose crosslinked), Ceteth-10 phosphate, Cetostearyl alcohol, Dihexadecyl phosphate, Dimethicone, Glyceryl 1-stearate, Hydroxyethly acrylate/sodium acryloydimethyl taurate copolymer, maltodextrin, polysorbate 80, SD alcohol, Steareth-21, water

Distributed By

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Questions

Call 1-888-296-9067

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEVING CREAM LIDOCAINE 
benzyl alcohol, lidocaine hci cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-139
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH)	BENZYL ALCOHOL	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
STEARETH-21 (UNII: 53J3F32P58)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-139-03	1 in 1 BOX	08/23/2023
1		85 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	08/23/2022

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)