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  5. Label Information: Balmex Diaper Rash

FDA Label for Balmex Diaper Rash

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENT
    11. QUESTIONS?
    12. PRINCIPAL DISPLAY PANEL - 113 G TUBE CARTON

Balmex Diaper Rash Product Label

The following document was submitted to the FDA by the labeler of this product Randob Labs,ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



Active ingredients Purpose
Zinc Oxide 11.3%Skin protectant

Uses



  • 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.


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



  • change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply cream 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 carton and or top of tube for lot number and expiration date

Inactive Ingredient



Inactive ingredients Beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europea (olive) leaf extract, panthenol, potassium aspartate, potassium hydroxide, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)


Questions?



1-833-389-9450

Dist. by: RANDOB LABS LTD. Box 440, Cornwall, NY 12518


Principal Display Panel - 113 G Tube Carton



NEW LOOK-SAME PRODUCT

Balmex®
COMPLETE
PROTECTION™

Zinc Oxide

DIAPER RASH CREAM

Prevents & Heals

* Please review the disclaimer below.