LANSINOH PAIN RELIEVING- lidocaine hcl spray

Lansinoh Pain Relieving by

Drug Labeling and Warnings

Lansinoh Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Lansinoh Laboratories Inc, Dhaliwal Pharmaceuticals Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

• Active Ingredient: Purpose
• Lidocaine 4%: Topical Analgesic

STOP USE AND ASK A DOCTOR

Stop use and ask a doctor if
■ Condition worsens
■ Symptoms persist for more than 7 days
■ Symptoms clear up and return within a
few day

ASK DOCTOR/PHARMACIST

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. Do
not use on infants or children under 12.

WARNINGS

Warnings
For external use only.
Do NOT use on breasts, nipples, in or
near mouth.
KEEP OUT OF REACH OF CHILDREN. Do
not use on infants or children under 12.
If swallowed, get medical help or contact
a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if
■ Condition worsens
■ Symptoms persist for more than 7 days
■ Symptoms clear up and return within a
few days

DOSAGE & ADMINISTRATION

Directions ■ For adult use only
■ Apply externally to the affected area not more than 3 - 4 times in a 24 hour period.

INACTIVE INGREDIENT

Inactive Ingredients:

Alcohol (Ethanol), Aloe Barbadensis Leaf Juice, Cellulose Gum, Eugenol, Hamamelis Virginiana (Witch Hazel) Water, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, PEG-40 Hydrogenated Castor Oil, Poloxamer 188, Potassium Sorbate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Benzoate, Sodium Phytate, Water.

Distributed By: Lansinoh Laboratories, Inc
Alexandria, VA 22314, USA
Tel: +1-800-292-4794 | www.lansinoh.com

WARNINGS

FOR EXTERNAL USE ONLY

INDICATIONS & USAGE

For external use only

PURPOSE

Topical Analgesic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANSINOH PAIN RELIEVING 
lidocaine hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53997-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHYTATE SODIUM (UNII: 88496G1ERL)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
EUGENOL (UNII: 3T8H1794QW)
ALCOHOL (UNII: 3K9958V90M)
WITCH HAZEL (UNII: 101I4J0U34)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLOXAMER 188 (UNII: LQA7B6G8JG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALMOND OIL (UNII: 66YXD4DKO9)
PEPPERMINT OIL (UNII: AV092KU4JH)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 2300 MPA.S AT 1%) (UNII: 0Z2R7OG99L)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53997-001-02	1 in 1 CARTON	02/15/2021
1	NDC: 53997-001-01	100 mL in 1 BOTTLE, PLASTIC; 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	02/15/2021

Labeler - Lansinoh Laboratories Inc (181696907)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Pharmaceuticals Laboratories LLC		116933772	manufacture(53997-001)