Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 380ffeae-f613-46f5-8b51-dff66ad832a6
Route
TOPICAL
Published
Effective Date 2013-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.5 mg) Zinc Oxide (10 mg)
Inactive Ingredients
Talc Acacia Eucalyptol Methyl Salicylate Salicylic Acid Thymol Zinc Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2003-08-12

Description

Menthol 0.15% Zinc oxide 1.0%

Purpose

External analgesic Skin protectant

Adverse Reactions

Vi-Jon One Swan Drive Smyrna, TN 37167


Medication Information

Purpose

External analgesic

Skin protectant

Adverse Reactions

Vi-Jon

One Swan Drive

Smyrna, TN 37167

Description

Menthol 0.15% Zinc oxide 1.0%

Uses

Uses for the temporary relief of paina and itching due to:

  • monor cuts
  • sunburn
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • scrapes
  • minor burns
  • minor skin irritations

dries the oozing and weeping of:

  • poison ivy
  • poison oak
  • poison sumac

Warnings

For external use only

Directions

adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

children under 2 years of age - do not use, consult a doctor

  • for best results dry skin thoroughly before applying
Disclaimer

This product is sold by weight, not by volume. Some settling may occur during handling and shipping

Made in the USA with US and foreign components

Active Ingredients

Menthol 0.15%

Zinc oxide 1.0%

Inactive Ingredients

 talc, acacia, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

Principal Display Panel

NDC 0869-0551-38

SWAN

medicated

Body Powder

skin protectant/topical analgesic

triple action

  • Cooling
  • Absorbing
  • Itch Relieving

Compare to Active Ingredients of Gold Bond Medicated Body Powder

NET WT 10 OZ (283 G)

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

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


Structured Label Content

Uses

Uses for the temporary relief of paina and itching due to:

  • monor cuts
  • sunburn
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • scrapes
  • minor burns
  • minor skin irritations

dries the oozing and weeping of:

  • poison ivy
  • poison oak
  • poison sumac

Purpose

External analgesic

Skin protectant

Warnings

For external use only

Directions

adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

children under 2 years of age - do not use, consult a doctor

  • for best results dry skin thoroughly before applying
Disclaimer (disclaimer)

This product is sold by weight, not by volume. Some settling may occur during handling and shipping

Made in the USA with US and foreign components

Adverse Reactions

Vi-Jon

One Swan Drive

Smyrna, TN 37167

Active Ingredients

Menthol 0.15%

Zinc oxide 1.0%

Inactive Ingredients (Inactive ingredients)

 talc, acacia, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

Principal Display Panel

NDC 0869-0551-38

SWAN

medicated

Body Powder

skin protectant/topical analgesic

triple action

  • Cooling
  • Absorbing
  • Itch Relieving

Compare to Active Ingredients of Gold Bond Medicated Body Powder

NET WT 10 OZ (283 G)

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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