Jell
FDA Label NDC 30400-215

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jell Pharmaceuticals Pvt Ltd. for the product Jell (NDC 30400-215). 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 ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, do not use on, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lanolin 15.5%

Petrolatum 53.4%

Purpose

Diaper rash ointment

Skin protectant

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor cuts, scrapes and burns ■ temporarily protects and relieve chapped,chafed or cracked skin or lips■ protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

When Using This Product

■ do not get into eyes

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

Do Not Use On

■ deep or puncture wounds ■ animal bites ■ serious burns

Keep Out Of Reach Of Children

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

Directions

■ for skin protectant use: ■ apply as needed ■ for diaper rash: ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

■ store at 20 to 25C (68-77F) ■ do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening

Inactive Ingredients

cod liver oil (contains vitamin A and vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

* Please review the disclaimer below.