RASH REPAIR BALM- zinc oxide ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Skinfix, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

SKIN PROTECTANT USES - HELPS TREAT AND PREVENT RASHES AND SKIN CHAFING DUE TO - EXPOSURE TO WETNESS AND FRICTION

Authorization status:

OTC monograph final

Summary of Product characteristics

RASH REPAIR BALM- ZINC OXIDE OINTMENT
SKINFIX, 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._
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ACTIVE INGREDIENT
ZINC OXIDE 20%
SKIN PROTECTANT
KEEP OUT OF REACH OF CHILDREN
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER
RIGHT AWAY
USES
HELPS TREAT AND PREVENT RASHES AND SKIN CHAFING DUE TO
EXPOSURE TO WETNESS AND FRICTION
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USEING THIS PRODUCT
AVOID CONTACT WITH EYES
STOP USE AND CONSULT A DOCTOR IF
CONDITIONS WORSENS
SYMPTOMS LAST MORE THAN 7 DAYS
OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS
DIRECTIONS
CLEANSE THE AFFECTED AREA AND ALLOW TO DRY
APPLY BALM LIBERALLY, REPEAT UP TO THREE TO FOUR TIMES DAILY
INACTIVE INGREDIENTS
ALLATOIN, ALOE BARBADENSIS LEAF JUICE, BEESWAX, GLYCINE SOJA (SOYBEAN)
OIL, HELIANTHUS ANNUUS (SUNFLOWER)
SEED OIL, LIQUIDAMBAR ORIENTALIS (ORINTAL SWEET GUM), MYROXYLON
BALSUMUM (BALSAM TOTU) RESIN, PARAFFIN,
PETROLATUM, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, SIMMONDSIA
CHINENSIS (JOJOBA) OIL, STYRAX BENZOIN
RESIN EXTRACT (BENZOIN), TOCOPHEROL
RASH REPAIR BALM
zinc oxide ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 1328 -110
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
.20 g in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PETRO LATUM (UNII: 4T6 H12BN9 U)
SO YBEAN O IL (UNII: 241ATL177A)
SUNFLO WER O IL (UNII: 3W1JG79 5YI)
JO JO BA O IL (UNII: 724GKU717M)
ALMO ND O IL (UNII: 6 6 YXD4DKO9 )
Skinfix, Inc.
TO CO PHERO L (UNII: R0 ZB2556 P8 )
YELLO W WAX (UNII: 2ZA36 H0 S2V)
PARAFFIN (UNII: I9 O0 E3H2ZE)
ALLANTO IN (UNII: 344S277G0 Z)
BENZO IN RESIN (UNII: GK21SBA74R)
LIQ UIDAMBAR O RIENTALIS RESIN (UNII: 6 3V9 1G4W9 3)
TO LU BALSAM (UNII: TD2LE9 1MBE)
ALO E VERA LEAF (UNII: ZY8 1Z8