FAMILY WELLNESS PAIN RELIEVING- menthol and methyl salicylate cream

Family Wellness Pain Relieving by

Drug Labeling and Warnings

Family Wellness Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Velocity Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients............. Purpose
Menthol 10%..................... Topical analgesic
Methyl salicylate 15%......... Topical analgesic

Active ingredients	Purpose
Menthol 10%	Topical analgesic
Methyl salicylate 15%	Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• 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 conditions

Ask a doctor before use if you have redness over the affected area.

When using this product

• avoid contact with eyes or 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 occurs

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• use only as directed
• adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

Other information

• store at 20° to 25°C (68° to 77°F)

Inactive ingredients

cetyl alcohol, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, phenoxyethanol, potassium cetyl phosphate, potassium hydroxide, propylparaben, stearic acid, water, xanthan gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS PAIN RELIEVING 
menthol and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-606
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
CETETH-20 (UNII: I835H2IHHX)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76168-606-12	1 in 1 CARTON	07/02/2020
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 not final	part348	07/02/2020

Labeler - Velocity Pharma LLC (962198409)