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:

Chattem, Inc.

INN (International Name):

ZINC OXIDE

Composition:

ZINC OXIDE 0.113 g in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin protectant - 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
CHATTEM, INC.
_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 CREAM
_ACTIVE INGREDIENT _
Zinc oxide 11.3%
_PURPOSE_
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)
Distributed by: CHATTEM, INC.
P.O. Box 2219, Chattanooga, TN 37409-0219
©2012 Chattem, Inc. 0042308-01
_PRINCIPAL DISPLAY PANEL_
NEW!
BALMEX®
ADULT CARE RASH CREAM
ZINC OXIDE 11.3% NEW WT 3 OZ (85G)
TM
_PRINCIPAL DISPLAY PANEL_
NEW!
BALMEX®
ADULT CARE RASH CREAM
ZINC OXIDE 11.3% NEW WT 3 OZ (85G)
TM
BALMEX ADULT CARE RASH
zinc oxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:4116 7-0 244
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STREN