DEBBIES DOWN AND DIRTY DEEP TISSUE JOINT AND MUSCLE- menthol cream 
DD&D Manufacturing Co., Ltd

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Debbie's Down & Dirty Deep Tissue Joint and Muscle Cream

Drug Facts

Active Ingredients

Menthol 10%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple back ache • arthritis • sprains • strains • and bruises

Warnings

For external use only

Do not apply

to wounds or damaged skin.

Ask a physician before use if

you have redness over the affected area.

When using this product

  • avoid contact with the eyes.
  • do not bandage.

Stop use and ask a physician if

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

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

Use only as directed Adults and children 12 years of age and older: apply generously to affected area. Massage into painful area until thoroughly absorbed into skin. Children under 12 years of age: consult a physician.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, Carbomer, Cetyl lcohol, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Methyl Salicylate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Salic Nigra (Willow Bark) Extract, Triethanolamine, Xanthan Gum.

Package labeling:

Label3

DEBBIES DOWN AND DIRTY DEEP TISSUE JOINT AND MUSCLE 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71523-833
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WILLOW BARK (UNII: S883J9JDYX)  
TROLAMINE (UNII: 9O3K93S3TK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
BROMELAINS (UNII: U182GP2CF3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71523-833-011 in 1 BOX06/28/2017
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/28/2017
Labeler - DD&D Manufacturing Co., Ltd (080655515)

Revised: 11/2023
Document Id: 09db6ba6-5806-44a5-e063-6294a90a072f
Set id: 531fe834-53e3-305f-e054-00144ff88e88
Version: 2
Effective Time: 20231111
 
DD&D Manufacturing Co., Ltd