BABYS BUTT AID - zinc oxide ointment 
HANGZHOU MINO DAILY CHEMICALS CO.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.

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Warnings

For external use only

  • flammable, keep away from fire and flame
  • will produce serious gastric disturbances if taken internally

Ask a doctor before use if you have deep puncture wounds or serious burns

When using this product

  • do not get into eyes or mucous membranes
  • use only in a well-ventilated area

Stop use and ask a doctor if condition persists or gets worse.

Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

Drug Facts

Active ingredient

Zinc Oxide 16%

Purpose

Skin Protectant

Uses

  • Helps treat and prevent diaper rash
  • Prevents chafed skin due to diaper rash 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 or does not improve within 7 days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Other information

store at 20 to 27 C (68 to 80.6 F)

Inactive ingredients

boric acid, castor oil, microcrystalline wax, mineral oil, paraffin, peruvian balsam, petrolatum

Baby Butt Aid LabelEnter section text here

BABYS BUTT AID 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35038-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4) 2 mL  in 100 mL
CASTOR OIL (UNII: D5340Y2I9G) 30 mL  in 100 mL
MINERAL OIL (UNII: T5L8T28FGP) 31.5 mL  in 100 mL
PARAFFIN (UNII: I9O0E3H2ZE) 10 mL  in 100 mL
PETROLATUM (UNII: 4T6H12BN9U) 10 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35038-100-2059 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2011
Labeler - HANGZHOU MINO DAILY CHEMICALS CO.LTD. (527974203)
Establishment
NameAddressID/FEIBusiness Operations
HANGZHOU MINO DAILY CHEMICALS CO.LTD.527974203manufacture

Revised: 2/2011
Document Id: a4c119dd-807f-416a-830a-ad379beb0f7c
Set id: a13302e9-b05c-4948-8267-40bc434c1013
Version: 1
Effective Time: 20110201
 
HANGZHOU MINO DAILY CHEMICALS CO.LTD.