DIAPERENE ADULT- menthol, zinc oxide ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Delsam Pharma Llc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

External Analgesic / Anti-itch Skin Protectant, Anorectal Astringent • Protects and Helps Heal Skin Irritations From • Incontinence of Urine or Diarrhea •  Feeding Tube Site Leakage • Diaper Rash • Wound Drainage • Minor Cuts & Scrapes • Bedsores • Burns/ Irradiated Skin • Temporarily Relieves Discomfort & Itching

Authorization status:

OTC monograph final

Summary of Product characteristics

DIAPERENE ADULT- MENTHOL, ZINC OXIDE OINTMENT
DELSAM PHARMA LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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_DELSAM PHARMA'S DIAPERENE_
_ ADULT_
_DRUG FACTS_
_ACTIVE INGREDIENT_
Menthol 0.44%
Zinc Oxide 20.6%.
_PURPOSE_
External Analgesic / Anti-itch
Skin Protectant, Anorectal Astringent
_USES_
• Protects and Helps Heal Skin Irritations From • Incontinence of
Urine or Diarrhea
• Feeding Tube Site Leakage • Diaper Rash • Wound Drainage •
Minor Cuts & Scrapes •
Bedsores • Burns/ Irradiated Skin • Temporarily Relieves
Discomfort & Itching
_WARNINGS_
FOR EXTERNAL USE ONLY. Not for deep or puncture wounds. Avoid contact
with eyes. In
case of accidental ingestion contact a physician or poison control
center immediately. If
condition worsens or does not improve within 7 days, consult a doctor.
WHEN USING THIS PRODUCT
• Certain persons can develop allergic reactions to ingredients in
this product.
• Do not put this product into the rectum by using fingers or any
mechanical device
or applicator. • Do not exceed the recommended daily dosage unless
directed by
a doctor.
STOP USE AND ASK A DOCTOR IF
• Bleeding occurs • Symptom being treated does not subside or if
redness,
irritation, swelling, pain or other symptoms develop or increase
• KEEP OUT OF REACH OF CHILDREN
_TM_
_DIRECTIONS_
Cleanse skin gently with mild skin cleanser. Pat dry or allow to air
dry. Apply a thin layer
of Diaperene Adult Ointment to reddened or irritated skin 2-4 times
daily, or after each
incontinent episode or diaper change to promote comfort and long
lasting protection.
OTHER INFORMATION
• Store between: 15-30°C (59-86°F)
_INACTIVE INGREDIENTS_
Lanolin, White soft paraffin, Light liquid paraffin, Calamine,
Glycerin, Propylene glycol
QUESTIONS OR COMMENTS
1-866-826-1306 between 11am to 4 pm EST, Monday-Friday (or) mail to
delasampharma@yahoo.