LANSINOH ANTI-ITCH- menthol 0.5% cream

Lansinoh Anti-itch by

Drug Labeling and Warnings

Lansinoh Anti-itch 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]

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Menthol 0.5%: Topical Analgesic

ASK DOCTOR

Stop Use and ask a doctor

• if condition worsens
• if symptoms persist for more than 7 days
• Or if symptoms clear up and occur again withina few days

ASK DOCTOR/PHARMACIST

DO NOT USE

Do NOT use in or near mouth, or on breasts or nipples when breast feeding.

Pregnant women are advised to consult their physician before using any OTC drug product.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

if swallowed, get medical help or contact a Poison Control Center right awau (1-800-222-1222)

PURPOSE

For temporary relief of itching

QUESTIONS

STOP USE

Stop use and ask a doctor

• If condition worsens
• If symptoms persists for more than 7 days
• Or if symptoms clear up and occur again within a few days

WARNINGS

Warnings

For external use only

Avoid contact withthe eyes

DOSAGE & ADMINISTRATION

Directions

• For adults and children 2 years and older
• Apply externally to the affected area, no more than 3-4 times daily

INACTIVE INGREDIENT

Inactive Ingredients:
Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Meal Extract, Caprylyl Glycol, Carbomer, Cetearyl Olivate, Cucumis Sativus Fruit Extract, Cyclopentasiloxane, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Glycerin, Hyaluronic Acid, Hydrolyzed Jojoba Esters, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isopropyl Palmitate, Polysorbate 60, Prunus Armeniaca (Apricot) Kernel Oil), Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Potassium Sorbate, Sodium Chloride, Sodium Hydroxide, Sorbitan Isostearate, 1,2-Hexanediol, Sorbitan Olivate, Squalane, Water (Eau, Aqua).

INDICATIONS & USAGE

Uses
For temporary relief of itching

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANSINOH ANTI-ITCH 
menthol 0.5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53997-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CUCUMBER (UNII: YY7C30VXJT)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
JOJOBA OIL (UNII: 724GKU717M)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
HYALURONIC ACID (UNII: S270N0TRQY)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
WATER (UNII: 059QF0KO0R)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN OLIVATE (UNII: MDL271E3GR)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
OATMEAL (UNII: 8PI54V663Y)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53997-002-02	1 in 1 CARTON	05/15/2024
1	NDC: 53997-002-01	125 mL 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	05/15/2024

Labeler - Lansinoh Laboratories Inc (181696907)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Pharmaceuticals Laboratories, LLC		116933772	manufacture(53997-002)