Label: SARNA- pramoxine hydrochloride, menthol lotion
- NDC Code(s): 0316-0234-12, 0316-0234-75
- Packager: Crown Laboratories, Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 31, 2024
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Beta-Glucan, Butylene Glycol, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Sodium Hydroxide, Stearic Acid, Tocopherol, Water
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Sarna Calm + Cool Principal Display Panel
#1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND
Sarna
Pramoxine Hydrochloride 1%
Menthol 0.5%
External Analgesic Lotion
Steroid Free
CALM + COOL
ANTI-ITCH LOTION
Eases pain and itch associated with insect bites, sunburn, and poison ivy
Infused with Witch Hazel Extract
Cools with Menthol
NET WT. 7.5fl oz (222 ml)
P12288.00
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INGREDIENTS AND APPEARANCE
SARNA
pramoxine hydrochloride, menthol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-0234 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1000 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.5 mg in 1000 mL Inactive Ingredients Ingredient Name Strength YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN) PEG-100 STEARATE (UNII: YD01N1999R) BENZYL ALCOHOL (UNII: LKG8494WBH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) ALOE VERA LEAF (UNII: ZY81Z83H0X) PEG-8 STEARATE (UNII: 2P9L47VI5E) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PALMITIC ACID (UNII: 2V16EO95H1) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARIC ACID (UNII: 4ELV7Z65AP) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-0234-75 222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/05/2024 2 NDC:0316-0234-12 355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/05/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 01/05/2024 Labeler - Crown Laboratories, Inc (079035945) Establishment Name Address ID/FEI Business Operations Crown Laboratories, Inc 079035945 manufacture(0316-0234) Establishment Name Address ID/FEI Business Operations VOYANT BEAUTY, INC. 243547333 manufacture(0316-0234)