Label: LEADER ANTI-ITCH- camphor, menthol lotion
- NDC Code(s): 70000-0546-1
- Packager: LEADER/Cardinal Health 110, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 4, 2024
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Active Ingredients
Camphor 0.5%............................................................................................................................ External analgesic
Menthol 0.5%.............................................................................................................................. External analgesic
- Uses
- Warning
- Purpose
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
LEADER ANTI-ITCH
camphor, menthol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0546 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.5 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) PEG-40 STEARATE (UNII: ECU18C66Q7) CETYL ALCOHOL (UNII: 936JST6JCN) PEG-100 STEARATE (UNII: YD01N1999R) STEARIC ACID (UNII: 4ELV7Z65AP) DMDM HYDANTOIN (UNII: BYR0546TOW) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER 940 (UNII: 4Q93RCW27E) PETROLATUM (UNII: 4T6H12BN9U) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0546-1 212 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 01/21/2020 Labeler - LEADER/Cardinal Health 110, Inc. (063997360) Registrant - Weeks & Leo Co., Inc. (005290028) Establishment Name Address ID/FEI Business Operations Weeks & Leo 005290028 manufacture(70000-0546)