CAREALL ARTHRITIS AND MUSCLE- capsaicin cream

CareALL Arthritis and Muscle by

Drug Labeling and Warnings

CareALL Arthritis and Muscle by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, sprains and bruises

Warnings

Warnings

For external use only.  Read all warnings and directions before use.  Test 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 or mucous membranes.  
• Do no apply immediately before or after activites such as bathing, swimming or sunbathing
• Do not banage tightly
• 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
• Do ot expose the area treated with product to heat or direct sunlight

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, swelling 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 under 18 years of age: ask a doctor

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL ARTHRITIS AND MUSCLE 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-094
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	.025 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-094-15	42.5 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/01/2022

Labeler - New World Imports, Inc (075372276)