Talc-free Medicated Body Powder

Talc-free Medicated Body Powder
SPL v4
SPL
SPL Set ID 27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b
Route
TOPICAL
Published
Effective Date 2018-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.15 g)
Inactive Ingredients
Starch, Corn Zinc Oxide Tricalcium Phosphate Sodium Bicarbonate Salicylic Acid Eucalyptus Oil Zinc Stearate Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-30

Description

Menthol 0.15%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Menthol 0.15%

Uses

Temporary relief of pain and itch associated with:

  • minor cuts
  • sunburn
  • insect bites
  • scrapes
  • minor burns
  • minor skin irritations
Warning
  • For external use only
  • Avoid contact with eyes
Directions

Remove seal beneath cap before first use. Do not use if seal is broken or missing.

  • adults and children 2 years and older - apply freely upto 3 or 4 times daily
  • children under 2 years - ask a doctor

For best results, dry skin throughly before applying

Active Ingredient

Menthol 0.15%

Inactive Ingredients

Zea Mays (Corn) Starch, zinc oxide, Tricalcium Phosphate, Sodium Bicarbonate, salicylic acid, zinc stearate, Eucalyptus oil, Peppermint Oil

Principal Display Panel

NDC 42669-209-01

Compare to active ingredient in Gold Bond® Medicated Body Powder*

talc-free medicated body powder

triple relief formulahelps absorb moisture

helps soothe skin and relieves itching

NET WT 10oz (283 g)

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within few days
Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a poison control center right away.


Structured Label Content

Uses

Temporary relief of pain and itch associated with:

  • minor cuts
  • sunburn
  • insect bites
  • scrapes
  • minor burns
  • minor skin irritations
Purpose

External Analgesic

Warning
  • For external use only
  • Avoid contact with eyes
Directions

Remove seal beneath cap before first use. Do not use if seal is broken or missing.

  • adults and children 2 years and older - apply freely upto 3 or 4 times daily
  • children under 2 years - ask a doctor

For best results, dry skin throughly before applying

Active Ingredient

Menthol 0.15%

Inactive Ingredients (Inactive ingredients)

Zea Mays (Corn) Starch, zinc oxide, Tricalcium Phosphate, Sodium Bicarbonate, salicylic acid, zinc stearate, Eucalyptus oil, Peppermint Oil

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 42669-209-01

Compare to active ingredient in Gold Bond® Medicated Body Powder*

talc-free medicated body powder

triple relief formulahelps absorb moisture

helps soothe skin and relieves itching

NET WT 10oz (283 g)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within few days
Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

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