Label: AXE BRAND MEDICATED- menthol, camphor and methyl salicylate oil
- NDC Code(s): 57538-003-01
- Packager: LEUNG KAI FOOK MEDICAL CO PTE LTD
- 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.
Drug Label Information
Updated November 13, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PurposeExternal analgesic
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
-
STOP USE
Stop use and ask a doctor if
condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive irritation of the skin develops
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurswhen using for pain of arthritis
pain persists for more than 10 days
redness is present
in conditions affecting children under 12 years of age - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
AXE BRAND MEDICATED
menthol, camphor and methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57538-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 16 g in 100 mL CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 5 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 g in 100 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) LAVENDER OIL (UNII: ZBP1YXW0H8) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57538-003-01 56 mL in 1 PACKAGE; Type 0: Not a Combination Product 04/13/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/13/2001 Labeler - LEUNG KAI FOOK MEDICAL CO PTE LTD (595107004) Establishment Name Address ID/FEI Business Operations LEUNG KAI FOOK MEDICAL CO PTE LTD 595107004 manufacture(57538-003)