Family Wellness Pain Relieving
FDA Label NDC 76168-606

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma Llc for the product Family Wellness Pain Relieving (NDC 76168-606). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, warnings, do not use, otc - ask doctor, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

Drug Facts

Otc - Active Ingredient

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

Otc - Purpose

Active ingredientsPurpose
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

Otc - Ask Doctor

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

Otc - Keep Out Of Reach Of Children

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

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