Label: AA TOP MEDICATED- menthol and methyl salicylate oil
Contains inactivated NDC Code(s)
NDC Code(s): 68233-810-01
- Packager: Albert Max, Inc.
- 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 January 12, 2018
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
For external Use Only
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 occurs
- adults and children 12 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 or 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage as shown in the illustrations.
- children under 12 years of age: consult your physician.
- refer to the above warnings; use otherwise than directed may be dangerous.
- Other information
Saposhnikoviae Radix, Artemisia Argyi Leaf, Moutan Cortex, Carpesii Fructus, Cimicifugae Rhizoma, Sophorae Flavescentis Radix, Impatiens Balsamina, Paeoniae Rubra Radix, Zanthoxyli Pericarpium, Glycyrrhizae Radix Et Rhizoma, Ocimum Basilicum, Notoginseng Radix Et Rhizoma, Carthami Flos, Ethyl Alcohol
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INGREDIENTS AND APPEARANCE
AA TOP MEDICATED
menthol and methyl salicylate oil
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68233-810 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.1 g in 1 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength IMPATIENS BALSAMINA WHOLE (UNII: ZMK32KX641) LICORICE (UNII: 61ZBX54883) OCIMUM BASILICUM WHOLE (UNII: P4815JL4O3) SAFFLOWER (UNII: 4VBL71TY4Y) SAPOSHNIKOVIA DIVARICATA WHOLE (UNII: LA61LWB4JH) PAEONIA X SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X) ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251) PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U) PAEONIA LACTIFLORA WHOLE (UNII: N44H57P7WG) ALCOHOL (UNII: 3K9958V90M) ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ) CARPESIUM ABROTANOIDES FRUIT (UNII: 20C78R73NH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68233-810-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/01/2018 Labeler - Albert Max, Inc. (149445798)