Skin Protectant For Babies And Kids Ointment
FDA Label NDC 13709-352

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Skin Protectant For Babies And Kids (NDC 13709-352). 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 drug facts: active ingredients, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, 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

→ Drug Facts: Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use On

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children

→ Directions

→ Storage

→ Inactive Ingredients

→ Tamper Evident

→ Principal Display Panel

Drug Facts: Active Ingredients

Lanolin 15.5%

Petrolatum 53.4%

Purpose

Lanolin - Skin protectant

Petrolatum - Skin protectant

Uses

Helps treat and prevent diaper rash
Temporarily protects minor cuts, scrapes, and burns
Relieves chapped, chafed, or cracked skin and lips
Protects from drying effects of wind and cold weather

Warnings

For external use only

Do Not Use On

deep or puncture wounds
animal bites
serious burns

When Using This Product

avoid contact with the 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.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

Skin protectant use: apply as needed
Diaper rash use:
Change wet and soiled diapers promptly
Cleanse the diaper area, and allow to dry
Apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged