Benson Bottom Paint: Package Insert and Label Information

BENSON BOTTOM PAINT- zinc oxide cream
Benson’s Bottom Paint , 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.

Drug Facts

Active Ingredient

Zinc Oxide 22%

Purpose

Skin Protectant

Uses

  • To help promote healing of diaper rash
  • To help prevent diaper rash
  • Good for bedsores and blisters

Warnings

For external use only

When using this product

  • Do not get into eyes

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days

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

Directions

  • liberally apply Benson’s Bottom Paint at first sign of redness or diaper rash daily until symptoms disappear.
  • apply after each change, especially at bedtime or whenever exposure to wet diapers may be prolonged

Other information

  • store at 20° to 30 ° C ( 68-86 °F)
  • may stain clothing

Inactive Ingredients

Water, Petrolatum, Stearyl Alcohol, Paraffin, Glycerin, Polysorbate 60, Sorbitan steareate, Polysorbate 20, Cetyl Alcohol, Emulsifying Wax, NF, Aminomethyl Propanol, Quaternium-15

Questions?

1-800-637-3882

Distributed in the U.S. by:
BENSON’S BOTTOM PAINT, INC.
P.O. Box 1531 • Muskegon, MI 49443-1531

PRINCIPAL DISPLAY PANEL — 170.1 gram Tube Label

Benson’s Bottom Paint

Soothes and Promotes Healing

Pediatrician recommended
Smooth, easy spreading
No odor
Isn’t greasy
Pharmacist formula

net weight 6 ounces
170.1 grams

PRINCIPAL DISPLAY PANEL -- 170.1 gram Tube Label
(click image for full-size original)
BENSON BOTTOM PAINT
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71706-060
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide (Zinc Oxide) Zinc Oxide 220 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Aminomethylpropanol
Polysorbate 20
Petrolatum
Stearyl Alcohol
Cetyl Alcohol
Paraffin
Sorbitan Monostearate
Polysorbate 60
Polawax Polysorbate
Quaternium-15 CIS-Form
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71706-060-06 170.1 g in 1 TUBE None
2 NDC:71706-060-02 56.7 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part346 10/01/2017
Labeler — Benson’s Bottom Paint , Inc (018703513)
Registrant — BMC 1092, Inc. dba Solo Laboratories, Inc (078831987)
Establishment
Name Address ID/FEI Operations
BMC 1092, Inc. dba Solo Laboratories, Inc 078831987 MANUFACTURE (71706-060)

Revised: 01/2020 Benson’s Bottom Paint , Inc

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