Family Wellness pain Relief Cream With Lidocaine

Family Wellness pain Relief Cream With Lidocaine
SPL v2
SPL
SPL Set ID 3a18119f-6c75-4cea-a990-97cb8a9589d4
Route
TOPICAL
Published
Effective Date 2024-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Carbomer Interpolymer Type A (55000 Cps) Aloe Vera Leaf Aminomethylpropanol C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Caprylyl Trisiloxane Cetostearyl Alcohol Ceteth-20 Phosphate Dihexadecyl Phosphate Dimethicone Edetate Disodium Ethylhexylglycerin Glyceryl Stearate Se Phenoxyethanol Alcohol Steareth-21 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-30

Description

Lidocaine HCL 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine HCL 4%

Uses 

Temporarily relieves minor pain

Active 

Lidocaine HCL 4%

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
Warnings 

For external use only

Questions ?

1-800-814-8028

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
Drug Facts 

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)

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 
Keep Out of Reach of Children

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

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.
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)


Structured Label Content

Uses 

Temporarily relieves minor pain

Purpose

Topical anesthetic

Active 

Lidocaine HCL 4%

Do Not Use (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
Warnings 

For external use only

Questions ?

1-800-814-8028

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
Drug Facts 

Other Information  (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)

When Using This Product  (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 
Keep Out of Reach of Children (Keep out of reach of children)

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

Stop Use and Ask A Doctor If  (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.
Principal Display Panel Tube  (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  (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)


Advanced Ingredient Data


Raw Label Data

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