FAMILY WELLNESS ULTRA STRENGTH MUSCLE RUB- ultra strength muscle rub cream

Family Wellness Ultra Strength Muscle Rub by

Drug Labeling and Warnings

Family Wellness Ultra Strength Muscle Rub by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR (Family Wellness). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Camphor- 4%

Menthol - 10%

Methyl salicylate -30%

Purpose

Topical Analgesic 

Topical Analgesic

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscle and joints associated with;

•  simple backaches, arthritis, strains, bruises and sprains

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 condiitions

Ask a doctor before use if you have; redness over thre affected area

When using this product 

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

Stop use and ask a doctor if;

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

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Use only as directed 

Adults and children 2 years of age and older;

• Apply to affected area not more than 3 to 4 times daily. 

Children under 2 years of age; ask a doctor.

Other information 

• Store at controlled room temperature 20°- 25°C ( 68° to 77°F)
• Close cap tightly afteruse.

Inactive ingredients 

Carbomer, Disodium ETDA, Glyceryl Sterate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Stearic Acid, Triethanolamine, Water (purified)

Questions?  1-800-814-8028

Principal Display Panel -Tube

Family Wellness               55319-820-57

Ultra Strength 

Pain Relief Cream 

Camphor 4%, Menthol 10%, Methyl Salicylate 30%

NET WT 2.0 OZ (57g)

Principal Display Panel - Carton 

Family Wellness       55319-820-57
Ultra Strength

Pain Relief Cream

Camphor 4%, Menthol 10%, Methyl Salicylate 30%

NET WT 2.0 OZ (57g)

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS ULTRA STRENGTH MUSCLE RUB 
ultra strength muscle rub cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-820
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
LANOLIN (UNII: 7EV65EAW6H)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-820-57	1 in 1 CARTON	09/30/2023
1		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/30/2023

Labeler - FAMILY DOLLAR (Family Wellness) (024472631)