CAREALL ARTHRITIS AND MUSCLE- capsaicin cream 
New World Imports, Inc

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.

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Active Ingredient

Capsaicin  0.025%

Purpose

Topical Analgesic

Keep out of Reach of Children

Keep out of Reach of Children.  If swallowed, get medical helpor contact a Posion Control Center immediately.

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backaches, strains, and sprains

Warnings

Warnings.For external use only.  Read all warnings and directions before use.  Tet first on small area of skin.

Do not use

  • On wounds or damaged skin
  • If you are allergic to capsicum or chili peppers

When using this product

  • You may experience a burning sensation.  The intensity of this reaction varies among individuals and may be severe.  With regular use, this sensation generally disappears after several days
  • Avoid contact with the eyes, lips, nose or mucous membranes.  If this occurs, rinse the affected area thoroughly with water
  • Do no apply immediately before or after activites such as bathing, swimming, sunbathing, or strenuous exercise
  • Do not tightly wrap or bandage the treated area
  • Do no apply heat to the treated area immediately before or after use
  • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin
  • Avoid inhaling airborne material from dried residue.  This can result in coughing, sneezing, tearing, or throat/respiratory irritation

Stop use and ask a doctor if:

  • Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
  • Severe burning persists, or blistering occurs
  • Difficulty breathing or swallowing occurs

If pregnant or breast feeding, ask a health professional before use.

Directions

Directions

Adults and children 18 years of age and older:

  • Apply a thin film of cream to affected area and gently rub in until fully absorbed
  • Unless treating hands, wash hand thoroughly with soap and water immediately after application
  • For best results, apply 3 to 4 times daily

Children 18 years of age and younger: ask a doctor

Inactive Ingredients

Benzyl Alcohol, Cetyl Alcohol, Citric Acid, Glyceryl Stearate, Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Purified Water, Sorbitol

CAP15 Carton Label

CAREALL ARTHRITIS AND MUSCLE 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-094
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.025 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-094-1542.5 g in 1 TUBE; Type 0: Not a Combination Product06/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2022
Labeler - New World Imports, Inc (075372276)

Revised: 4/2022
 
New World Imports, Inc