FAMILY WELLNESS PAIN RELIEF WITH LIDOCAINE- pain relief with lidocaine cream

Family Wellness Pain Relief with Lidocaine by

Drug Labeling and Warnings

Family Wellness Pain Relief with Lidocaine 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 

Lidocaine HCL 4%

Purpose

Topical anesthetic

Uses 

Temporarily relieves minor pain

Warnings 

For external use only

Do not use

• on large areas of the body or on cut,irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor

When using this product 

• use only as directed. Read and follow all directions and warnings on this carton.
• do not allow contact with the eyes or mucous membranes
• do not bandage or apply local heat (such as heating pads) to the area of use.
• do not use at the same time as other topcial analgesics 

Stop use and ask a doctor if 

• condition worsens
• symptons persist for more than 7 days or clear up and occur again within a few days.
• If pregnant or breast feeding, ask a health professional before use.
• If pregnant or breast-feeding- ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Directions 

• Adults and children over 12 years:
• apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
• Children under 12 years or younger: ask a doctor

Other information 

Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients 

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Phenoxyethanol, SD Alcohol 40, Steareth-21, Water (purified)

Questions ?

1-800-814-8028

Principal Display panel -Tube 

Family Wellness          NDC: 55319-822-50

Pain Relief Cream 

Lidocaine HCL 4% 

Topical Anesthetic 

NET WT. 1.75 OZ (49.6g)

Principal Display Panel -Carton 

Family Wellness NDC: 55319-822-50

Pain Relief Cream

Lidocaine HCL 4%

Topical Anesthetic

NET WT. 1.75 OZ (49.6g)

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS PAIN RELIEF WITH LIDOCAINE 
pain relief with lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-822
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOl (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
Dihexadecyl phosphate (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALCOHOL (UNII: 3K9958V90M)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-822-50	1 in 1 CARTON	09/30/2023
1		49.6 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)