Label: WALGREENS PAIN RELIEVING ANALGESIC (camphor- synthetic, menthol, unspecified form, and methyl salicylate cream
- NDC Code(s): 0363-1199-01
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated March 25, 2020
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
For external use only. ALLERGY ALERT if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. Avoid contact with eyes and mucous membranes.
Do not use
- for arthritis-like conditions in children under 12. Consult a doctor.
- with a heating pad
- on wounds or damaged skin
Stop use and consult a doctor if
- condition worsens or pain lasts for more than 7 days or clear up and occur again within a few days
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
INGREDIENTS AND APPEARANCE
WALGREENS PAIN RELIEVING ANALGESIC
camphor (synthetic), menthol, unspecified form, and methyl salicylate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1199 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 40 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 100 mg in 1 g Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate 300 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) Glyceryl Stearate SE (UNII: FCZ5MH785I) Lanolin (UNII: 7EV65EAW6H) Polysorbate 80 (UNII: 6OZP39ZG8H) Potassium Hydroxide (UNII: WZH3C48M4T) Stearic Acid (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1199-01 1 in 1 CARTON 02/11/2020 1 113 g 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 NOT FINAL part348 02/11/2020 Labeler - Walgreen Company (008965063) Registrant - Garcoa, Inc (036464697) Establishment Name Address ID/FEI Business Operations Sigan Industries INC. 255106239 MANUFACTURE(0363-1199)