OTC Medication Information: DR. WALTONS BABY POWDER

DR. WALTONS BABY POWDER- alpha-tocopherol and zinc oxide 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.

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

DR. WALTONS BABY POWDER talc powder

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76271-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 5.2 g in 675 g ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 5.13 g in 675 g

Inactive Ingredients Ingredient Name Strength TALC

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76271-001-24 675 g in 1 BOTTLE, PLASTIC None 2 NDC:76271-001-02 55 g in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part347 07/09/2011

Labeler — Dr. Waltons, Incorporated (041377104)

Revised: 02/2012 Dr. Waltons, Incorporated