FDA Label for Diaper Rash

View Indications, Usage & Precautions

Diaper Rash Product Label

The following document was submitted to the FDA by the labeler of this product Goodsense. 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

Distributed by:
Perrigo Direct, Inc.
Peachtree City, GA 30269


Active Ingredient



Zinc oxide 40%


Purpose



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.

Avoid contact with 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 right away: 800-222-1222.


Directions



  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • 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



  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients



aloe barbadensis leaf juice, BHA, cetyl alcohol, coconut butter, corn starch, fragrance, hydroxyethylcellulose, lanolin, methylparaben, mineral oil, petrolatum, polysorbate 20, purified water, shea butter


Questions Or Comments?



866-323-0107 or www.natureplex.com


Principal Display Panel - 56.7 G Tube Carton



GOODSENSE®
NDC 50804-079-01

Maximum Strength

Diaper Rash Paste

40% Zinc Oxide

Soothes Burning
Prevents Diaper Rash
Protects Skin

NET WT 2 oz (56.7 g)

Compare to active ingredients of
Desitin® Maximum Strength*


* Please review the disclaimer below.