FAMILY WELLNESS HOT AND COLD PAIN RELIEF- hot and cold pain relief cream 
FAMILY DOLLAR (Family Wellness)

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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Family Wellness Hot and Cold Pain Relief

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;

Warning

For external use only

Do not use

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

When using this product 

Stop use and ask a doctor if;

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

Directions

Adults and children 2 years of age and older;

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)

FD_ColdHot PainRelief_Tube

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)

FD_ColdHotPainRelief_Carton

FAMILY WELLNESS HOT AND COLD PAIN RELIEF 
hot and cold pain relief cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-824
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-824-351 in 1 CARTON09/30/2023
135.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/30/2023
Labeler - FAMILY DOLLAR (Family Wellness) (024472631)

Revised: 8/2023
Document Id: 9ea9c87a-6755-4f3c-95ff-2df806d74780
Set id: b70e343b-18aa-4e45-ae8e-79d8c84ad205
Version: 2
Effective Time: 20230830
 
FAMILY DOLLAR (Family Wellness)