Gold Bond Medicated Anti-itch Lotion
FDA Label NDC 84714-0507

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gold Bond Co Llc for the product Gold Bond Medicated Anti-itch (NDC 84714-0507). 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, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 0.5%
Pramoxine hydrochloride 1%

Purpose

Anti-itch
Anti-itch

Use

for temporary relief of pain and itching associated with:

■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites ■ minor skin irritations

Warnings

For external use only

When Using This Product

■ avoid contact with eyes

Stop Use And Ask A Doctor If

■ condition worsens

■ 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 immediately.

Directions

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

children under 2 years of age: consult a doctor

Inactive Ingredients

water, glycerin, dimethicone, cetyl alcohol, petrolatum, distearyldimonium chloride, aloe barbadensis leaf juice, glyceryl stearate, stearyl alcohol, cetearyl alcohol, behentrimonium methosulfate, steareth-21, propylene glycol, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, diazolidinyl urea, butylene glycol, tocopheryl acetate, potassium hydroxide, methylparaben, panthenol, ethoxydiglycol, EDTA, avena sativa (oat) kernel extract

Principal Display Panel

GOLD BOND
ANTI-ITCH LOTION
Net wt 5.5 oz (155 g)

Gold Bondanti-itch Lotionnet Wt 5.5 Oz (155 G) (Gold Bond Medicated Intensive Relief Anti Itch Lot 01)

Gold Bondanti-itch Lotionnet Wt 5.5 Oz (155 G) (Gold Bond Medicated Intensive Relief Anti Itch Lot 01)

Gold Bondanti-itch Lotionnet Wt 5.5 Oz (155 G) (Gold Bond Medicated Intensive Relief Anti Itch Lot 02)

Gold Bondanti-itch Lotionnet Wt 5.5 Oz (155 G) (Gold Bond Medicated Intensive Relief Anti Itch Lot 02)

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