LANSINOH ANTI-ITCH- menthol 0.5% cream 
Lansinoh Laboratories Inc

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Lansinoh Anti Itch

Active IngredientsPurpose
Menthol 0.5%Topical Analgesic

Stop Use and ask a doctor

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

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

For temporary relief of itching

Stop use and ask a doctor

Warnings

For external use only

Avoid contact withthe eyes

Directions

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).

Uses
For temporary relief of itching

Drug fact and front

front

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LANSINOH ANTI-ITCH 
menthol 0.5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53997-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53997-002-021 in 1 CARTON05/15/2024
1NDC:53997-002-01125 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/15/2024
Labeler - Lansinoh Laboratories Inc (181696907)
Establishment
NameAddressID/FEIBusiness Operations
Dhaliwal Pharmaceuticals Laboratories, LLC116933772manufacture(53997-002)

Revised: 5/2024
Document Id: 19357c7f-b7fb-dacc-e063-6394a90ad1c1
Set id: 19357c7f-b7fa-dacc-e063-6394a90ad1c1
Version: 1
Effective Time: 20240524
 
Lansinoh Laboratories Inc