Ivy-dry Super Pump Spray

Ivy-dry Super Pump Spray
SPL v5
SPL
SPL Set ID 4792a667-2378-4b3d-968d-9efb1866792f
Route
TOPICAL
Published
Effective Date 2012-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzyl Alcohol (100 mg) Camphor (synthetic) (5 mg) Menthol (2.5 mg)
Inactive Ingredients
Water Zinc Acetate Isoceteth-20 Zinc Lactate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-05-21

Description

Benzyl Alcohol 10% Camphor 0.5% Menthol 0.25%

Purpose

External Analgesic


Medication Information

Warnings and Precautions

For external use only.

Purpose

External Analgesic



Description

Benzyl Alcohol 10% Camphor 0.5% Menthol 0.25%

Uses
  • for the temporary relief of itching associated with insect bites and minor skin irritations
Directions
  • Apply to affected area not more than 3 times daily.
  • Children under 6 years of age: do not use, ask a doctor.
  • Severe reactions to Urushiol (the chemical released by the plant, which causes the irritation) can look like chemical burns and have a thick leathery appearance. Additional applications may be necessary.

  • Test product on small patch of skin before applying to the entire body.
Do Not Use
  • on face or genital areas

  • on areas of blistered or broken skin
  • with a compress after application

Package Labeling



Ivy-Dry Super

TEMPORARY RELIEF OF PAIN AND ITCHING

Associated with Minor Skin Irritations and Insect Bites

External Analgesic



Manufactured in the USA for:

Ivy-Dry, Inc.

299-B Fairfield Avenue

Fairfield, NJ 07070



©2012 Ivy-Dry, Inc.

Questions or Comments www.ivydry.com





Other Information

Store at room temperature

You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222



Active Ingredients

Benzyl Alcohol 10%

Camphor 0.5%

Menthol 0.25%



Inactive Information

WATER, ISOPROPANOL, ZINC ACETATE, ISOCETETH-20, ZINC LACTATE

When Using This Product
  • do not get into eyes
  • if contact occurs, flush eyes with water
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast Feeding,

ask a doctor before use.

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • for the temporary relief of itching associated with insect bites and minor skin irritations
Warnings and Precautions (34071-1)

For external use only.

Purpose

External Analgesic



Directions
  • Apply to affected area not more than 3 times daily.
  • Children under 6 years of age: do not use, ask a doctor.
  • Severe reactions to Urushiol (the chemical released by the plant, which causes the irritation) can look like chemical burns and have a thick leathery appearance. Additional applications may be necessary.

  • Test product on small patch of skin before applying to the entire body.
Do Not Use (Do not use)
  • on face or genital areas

  • on areas of blistered or broken skin
  • with a compress after application

Package Labeling



Ivy-Dry Super

TEMPORARY RELIEF OF PAIN AND ITCHING

Associated with Minor Skin Irritations and Insect Bites

External Analgesic



Manufactured in the USA for:

Ivy-Dry, Inc.

299-B Fairfield Avenue

Fairfield, NJ 07070



©2012 Ivy-Dry, Inc.

Questions or Comments www.ivydry.com





Other Information (Other information)

Store at room temperature

You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222



Active Ingredients

Benzyl Alcohol 10%

Camphor 0.5%

Menthol 0.25%



Inactive Information

WATER, ISOPROPANOL, ZINC ACETATE, ISOCETETH-20, ZINC LACTATE

When Using This Product (When using this product)
  • do not get into eyes
  • if contact occurs, flush eyes with water
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a doctor before use.

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

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


Advanced Ingredient Data


Raw Label Data

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