BENSON BOTTOM PAINT- zinc oxide cream

Benson Bottom Paint by

Drug Labeling and Warnings

Benson Bottom Paint by is a Otc medication manufactured, distributed, or labeled by Benson's Bottom Paint , Inc, Solo Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BENSON BOTTOM PAINT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71706-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	220 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Aminomethylpropanol (UNII: LU49E6626Q)
Polysorbate 20 (UNII: 7T1F30V5YH)
Petrolatum (UNII: 4T6H12BN9U)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Cetyl Alcohol (UNII: 936JST6JCN)
Paraffin (UNII: I9O0E3H2ZE)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Polysorbate 60 (UNII: CAL22UVI4M)
Polawax Polysorbate (UNII: Q504PL8E0V)
Quaternium-15 CIS-Form (UNII: LIT014L4RH)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71706-060-06	170.1 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2017
2	NDC: 71706-060-02	56.7 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2017

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	Business Operations
BMC 1092, Inc. dba Solo Laboratories, Inc		078831987	MANUFACTURE(71706-060)