ASTONEA CARE MUSCLE AND JOIN PAIN RELIEF CREAM- menthol, methyl salicylate cream 
ASTONEA LABS PRIVATE LIMITED

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ASTONEA CARE Muscle & Join Pain Relief Cream

Drug Facts

Menthol 10%

Methyl salicylate 15%

Active ingredientsPurpose
Menthol 10%Topical analgesic
Methyl salicylate 15%Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

Warnings

For external use only.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you haveredness over the affected area

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

  • excessive skin irritation occurs
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Other information

store at 20° to 25°C (68° to 77°F)

do not use if tube seal under cap is broken

Inactive ingredients

borax, butylated hydroxytoluene, carbopol 940, cetostearyl alcohol, cetyl alcohol, glycerol monostearate, peg 100 stearate, phenoxyethanol, sodium benzoate, stearic acid, trolamine, tween 60, water

Muscle & Joint Pain Relief Cream

Principal Display and Drug Fact Panel

ASTONEA CARE MUSCLE AND JOIN PAIN RELIEF CREAM 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-212-021 in 1 CARTON03/05/2024
156.6 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/05/2024
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 3/2024
Document Id: 12eeea46-ec07-526c-e063-6294a90a96b3
Set id: 12eeec63-cfc4-7540-e063-6394a90a65f0
Version: 1
Effective Time: 20240305
 
ASTONEA LABS PRIVATE LIMITED