FAMILY WELLNESS HOT AND COLD PAIN RELIEF- hot and cold pain relief cream

Family Wellness Hot and Cold Pain Relief by

Drug Labeling and Warnings

Family Wellness Hot and Cold Pain Relief 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 

Menthol - 10%

Methyl salicylate -30%

Purpose

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

Warning

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)

Inactive ingredients 

Questions? 1-800 814-8028

Principal Display Panel -Tube

Family Wellness          NDC: 55319-824-35

Cold & Hot Pain Relief Cream 

MENTHOL 10%

METHYL SALICYLATE 30%

NET WT 1.25 OZ (35.4g)

Principal Display Panel -Carton 

Family Wellness       NDC: 55319-824-35

Cold & Hot Pain Relief Cream

MENTHOL 10%

METHYL SALICYLATE 30%

NET WT 1.25 OZ (35.4g)

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS HOT AND COLD PAIN RELIEF 
hot and cold pain relief cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-824
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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)
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: 55319-824-35	1 in 1 CARTON	09/30/2023
1		35.4 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 Drug	M017	09/30/2023

Labeler - FAMILY DOLLAR (Family Wellness) (024472631)