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Name:Babys Butt Aid
Manufacturer:Hangzhou Mino Daily Chemicals Co.ltd.
Category:Over-the-counter (OTC) Marketed Drugs


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 Type HUMAN OTC DRUG Item Code (Source) NDC:35038-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 16 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID 2 mL  in 100 mL
CASTOR OIL 30 mL  in 100 mL
MINERAL OIL 31.5 mL  in 100 mL
PARAFFIN 10 mL  in 100 mL
PETROLATUM 10 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35038-100-20 59 mL in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2011

Labeler - HANGZHOU MINO DAILY CHEMICALS CO.LTD. (527974203)
Establishment
Name Address ID/FEI Operations
HANGZHOU MINO DAILY CHEMICALS CO.LTD. 527974203 manufacture

Revised: 02/2011 HANGZHOU MINO DAILY CHEMICALS CO.LTD.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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