Ivy Dry
FDA Label NDC 49546-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ivy Dry, Inc. for the product Ivy Dry (NDC 49546-201). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Benzyl Alcohol 10%
Camphor 0.6%
Menthol 0.4%

Uses

for the temporary relief of itching associated with insect bites and minor skin irritations.

Warnings

For external use only.

Directions

  • Apply to affected area not more than 3 times daily.
  • Children under 2 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.

Other Information

  • Store at room temperature.
  • You may report a serious adverse reaction to Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222.

Inactive Ingredients

Water, Structure XL, Cutina GMS, Phenoxol T, Cremaphor CO 40, Butylene Glycol, Zinc Acetate, Steareth-2,
Steareth-20, Steareth 100, Proaqua ISL, Pelemol IPM, Estol 1543, Glydant Plus, Dimethicone, VE Acetate, Allantoin.

Product Labeling

TEMPORARY
RELIEF
OF PAIN
AND ITCHING
Associated with Minor Skin
Irritations and Insect Bites
External Analgesic


Ivy Dry Cream (Ivydrycream)

Ivy Dry Cream (Ivydrycream)

Ivy Dry Cream (Ivydrycream2)

Ivy Dry Cream (Ivydrycream2)

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