Other
Drug Facts
Distributed by RANDOB LABS LTD.
Box 440, Cornwall, NY 12518
Balmex Multi-purpose Ointment
FDA Label NDC 52412-450
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Randob Labs,ltd. for the product Balmex Multi-purpose (NDC 52412-450). 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 other, otc - purpose, uses, warnings, when using this product, stop use and ask a doctor if, do not use on, otc - 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
Otc - Purpose
| Active ingredients | Purpose |
Petrolatum 51.1% | Skin protectant |
Uses
- temporarily protects minor
- cuts
- scrapes
- burns
- temporarily protects and helps relieve chapped or cracked skin
- helps treat and prevent diaper rash
- 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- apply as needed
- change wet or 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 any time when exposure to wet diapers may be prolonged
Other Information
- do not use if quality seal is broken
- see bottom of tube for lot number and expiration date
Inactive Ingredients
acacia farnesiana flower extract, allantoin, aloe barbadenis leaf extract, chamomilla recutita (matricaria) flower extract, cholecalciferol, cyclomethicone, dimethicone, fragrance, isopropyl myristate, isopropyl palmitate, lavandula angustifolia (lavender) extract, mineral oil, polyethylene, retinyl palmitate, rosmarinus officinalis (rosemary) extract, silica, tocopheryl acetate, zea mays (corn) oil (245-276)
Questions?
1-833-389-9450
Principal Display Panel - 99 G Tube Label
NEW LOOK-SAME PRODUCT
Balmex®
MULTI-PURPOSE
HEALING OINTMENT
Skin Protectant-Petrolatum 51.1%
From diaper rash to
chapped, chafed skin
✔ Heals, protects & soothes✔ 7 healing moisturizers
plus Vitamin A & Vitamin D✔ Clear and easy to apply
Pediatrician Recommended
NET WT
3.5 OZ
(99 g)
Principal Display Panel (99 g Tube Label)
* Please review the disclaimer below.
