BALMEX ADULT CARE RASH- zinc oxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)

Available from:

Randob Labs,Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- helps relieve and prevent rashes and irritation due to wetness from incontinence - protects chafed skin due to irritation and helps seal out wetness

Authorization status:

OTC monograph final

Summary of Product characteristics

BALMEX ADULT CARE RASH- ZINC OXIDE CREAM
RANDOB LABS,LTD.
_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._
----------
BALMEX ADULT CARE RASH
_DRUG FACTS_
_ACTIVE INGREDIENTS _
_PURPOSE_
Zinc Oxide 11.3%
Skin
protectant
_USES_
helps relieve and prevent rashes and irritation due to wetness from
incontinence
protects chafed skin due to irritation and helps seal out wetness
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
avoid contact with eyes
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms persist 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
immediately.
_DIRECTIONS_
gently cleanse affected skin
pat dry with a clean, soft cloth or allow to air dry
apply generously to affected area as needed, especially after
incontinence episodes
using a dry tissue to remove excess product from skin is most
effective
_INACTIVE INGREDIENTS _mineral oil, water, beeswax, microcrystalline
wax, synthetic beeswax, fragrance,
sorbitan sesquioleate, oenothera biennis (evening primrose) seed
extract, olea europaea (olive) leaf
extract, dimethicone, tocopherol, methylparaben, glycine soja
(soybean) oil, propylparaben, panthenol,
sarcosine, benzoic acid, potassium aspartate, potassium hydroxide,
magnesium aspartate, sodium cocoyl
amino acids (309-021)
For more information please visit
www.BalmexAdult.com
Distributed by _RANDOB_ LABS LTD.
Box 440, Cornwall, NY 12518
®
™
PRINCIPAL DISPLAY PANEL - 85 G TUBE CARTON
Activ
Guard™
NEUTRALIZES
IRRITANTS
Balmex
ADULTCARE
RASH CREAM
ZINC OXIDE 11.3%
Soothes &
Protects Skin
From Irritation, Chafing & Rash
Dermatologist Tested
Works in One Use*
Odor-Free
NET WT 3 OZ (85 g)
®
™
BALMEX ADULT CARE RASH
zinc oxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:52412-50 0
ROUTE OF AD