DR. WALTONS BABY POWDER- talc powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Dr. Waltons, Incorporated

INN (International Name):

ALPHA-TOCOPHEROL

Composition:

ALPHA-TOCOPHEROL 5.2 g in 675 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

GREAT FOR YOUR BABY: PREVENTS AND SOOTHES DIAPER RASH, ELIMINATES ODOR. USE AFTER EVERY BATH AND DIAPER CHANGE. GREAT FOR YOU: USE DAILY FOR SOFT, IRRITATION-FREE SKIN. REDUCES CHAFING AND ABSORBS MOISTURE. GREAT FOR ELIMINATING SAND AND MOISTURE AFTER A DAY AT THE BEACH! CAUTION: KEEP OUT OF CHILDREN'S REACH. AVOID BABY'S EYES, NOSE AND MOUTH. NOT FOR USE ON BROKEN SKIN. IF IRRITATION DEVELOPS, PLEASE DISCONTINUE USE. HYPOALLERGENIC; DERMATOLOGIST AND ALLERGY TESTED; PEDIATRICIAN TESTED PREVENTS AND SOOTHES DIAPER RASH, ELIMINATES ODOR

Authorization status:

OTC monograph not final

Summary of Product characteristics

DR. WALTONS BABY POWDER- TALC POWDER
DR. WALTONS, INCORPORATED
_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._
----------
DRUG FACTS
KEEP OUT OF CHILDREN'S REACH. AVOID BABY'S EYES, NOSE AND MOUTH.
GREAT FOR YOUR BABY: PREVENTS AND SOOTHES DIAPER RASH, ELIMINATES
ODOR.
USE AFTER EVERY BATH AND DIAPER CHANGE.
GREAT FOR YOU: USE DAILY FOR SOFT, IRRITATION-FREE SKIN. REDUCES
CHAFING
AND ABSORBS MOISTURE. GREAT FOR ELIMINATING SAND AND MOISTURE AFTER A
DAY AT THE BEACH!
CAUTION: KEEP OUT OF CHILDREN'S REACH. AVOID BABY'S EYES, NOSE AND
MOUTH.
NOT FOR USE ON BROKEN SKIN. IF IRRITATION DEVELOPS, PLEASE DISCONTINUE
USE.
HYPOALLERGENIC; DERMATOLOGIST AND ALLERGY TESTED; PEDIATRICIAN TESTED
IF IRRITATION DEVELOPS, PLEASE DISCONTINUE USE.
PREVENTS AND SOOTHES DIAPER RASH, ELIMINATES ODOR
SHAKE POWDER ONTO HANDS AND GENTLY RUB ONTO SKIN
TALC
VITAMIN E (ALPHA-TOCOPHEROL), ZINC OXIDE
Enter section text here
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Dr. Waltons, Incorporated
DR. WALTONS BABY POWDER
talc powder
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:76 271-0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N8
55PNZ1)
ALPHA-TOCOPHEROL 5.2 g in 6 75 g
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
5.13 g in 6 75 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
TALC (UNII: 7SEV7J4R1U)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:76 271-0 0 1-24
6 75 g in 1 BOTTLE, PLASTIC
2
NDC:76 271-0 0 1-0 2
55 g in 1 BOTTLE, PLASTIC
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt347
0 7/0 9 /20 11
LABELER -
Dr. Waltons, Incorporated (041377104)
Revised: 2/2012