OTC Medication Information: Lidocaine HCl 4 Percent and Menthol 4 Percent

LIDOCAINE HCL 4 PERCENT AND MENTHOL 4 PERCENT- lidocaine hydrochloride and menthol, unspecified form spray
Preferred Pharmaceuticals, 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.

LIDOCAINE AND MENTHOL — Lidocaine HCl 4% and Menthol 4% topical spray
7T Pharma, LLC

Lidocaine 4% and Menthol 4% Topical Spray

​Drug Facts

Active ingredient

Lidocaine HCl 4%

Menthol 4%

Purpose

Topical anesthetic
Topical analgesic

Uses

Temporarily relieves pain and itching due to:

minor cuts
sunburn
minor scrapes
minor burns
insect bites
minor skin irritations

Warnings

​For external use only.

When using this product

do not use in or near the eyes
do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

allergic reaction occurs
condition worsens or does not improve within 7 days
symptoms clear up and return within a few days
redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children.

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

Directions

adults and children 2 years and older

apply externally to the affected area up to 3 to 4 times a day

children under 2 years

ask a doctor

Other information

May be applied under occlusive dressing.
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Myristoleate, Ethylhexylglycerin, Glycyrrhiza Glabra (Licorice) Extract, Ilex Paraguaiensis (Yerba Mate) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B

Lidocaine 4% and Menthol 4% Topical Spray

NDC 68788-7434-01

4 fl oz (118mL)

Manufactured for:
7T Pharma, LLC
Los Angeles, CA 90064

Relabeled by Preferred Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL

NDC 68788-7434-01
LIDOCAINE 4%
AND
MENTHOL 4%
topical spray
4 Fl oz. (118 mL)

Lidocaine 4% & Menthol 4% Topical Spray
(click image for full-size original)
LIDOCAINE HCL 4 PERCENT AND MENTHOL 4 PERCENT
lidocaine hcl and menthol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7434(NDC:70645-263)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 mL
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
WATER
ARNICA MONTANA FLOWER
INDIAN FRANKINCENSE
CETYL MYRISTOLEATE
ETHYLHEXYLGLYCERIN
GLYCYRRHIZA GLABRA
ILEX PARAGUARIENSIS LEAF
MAGNESIUM SULFATE, UNSPECIFIED FORM
DIMETHYL SULFONE
PHENOXYETHANOL
POLYSORBATE 20
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7434-1 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/01/2020
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 RELABEL (68788-7434)

Revised: 06/2020 Preferred Pharmaceuticals, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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