The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Gold Bond Intensive Relief Anti-itch (NDC 41167-0507). 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 purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Menthol 0.5%....................................................................................................................................Anti-itch
Pramoxine hydrochloride 1%............................................................................................................Anti-itch
for temporary relief of pain and itching associated with:
■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites ■ minor skin irritations
For external use only
■ avoid contact with eyes
■ condition worsens
■ symptoms persist for more than 7 days or clear up and occur again within a few days
If swallowed, get medical help or contact a Poison Control Center immediately.
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
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
GOLD BOND
ANTI-ITCH LOTION
INTENSIVE RELIEF
Net wt 5.5 oz (155 g)
Principal Display Panelgold Bondanti-itch Lotionintensive Reliefnet Wt 5.5 Oz (155 G) (Gold Bond Intensive Relief Anti Itch 01)
Principal Display Panelgold Bondanti-itch Lotionintensive Reliefnet Wt 5.5 Oz (155 G) (Gold Bond Intensive Relief Anti Itch 02)
* Please review the disclaimer below.
