DIAPER RASH- zinc oxide paste

Diaper Rash by

Drug Labeling and Warnings

Diaper Rash by is a Otc medication manufactured, distributed, or labeled by GOODSENSE, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc oxide 40%

Purpose

Skin protectant

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only.

Avoid contact with 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. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

• change wet and soiled diapers promptly
• cleanse the diaper area
• 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 15 to 30°C (59 to 86°F)
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

aloe barbadensis leaf juice, BHA, cetyl alcohol, coconut butter, corn starch, fragrance, hydroxyethylcellulose, lanolin, methylparaben, mineral oil, petrolatum, polysorbate 20, purified water, shea butter

Questions or comments?

866-323-0107 or www.natureplex.com

SPL UNCLASSIFIED SECTION

Distributed by:
Perrigo Direct, Inc.
Peachtree City, GA 30269

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

GOODSENSE®
NDC: 50804-079-01

Maximum Strength

Diaper Rash Paste

40% Zinc Oxide

Soothes Burning
Prevents Diaper Rash
Protects Skin

NET WT 2 oz (56.7 g)

Compare to active ingredients of
Desitin® Maximum Strength*

INGREDIENTS AND APPEARANCE

DIAPER RASH 
zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Butylated Hydroxyanisole (UNII: REK4960K2U)
Cetyl Alcohol (UNII: 936JST6JCN)
Cocoa Butter (UNII: 512OYT1CRR)
Starch, Corn (UNII: O8232NY3SJ)
Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)
Lanolin (UNII: 7EV65EAW6H)
Methylparaben (UNII: A2I8C7HI9T)
Mineral Oil (UNII: T5L8T28FGP)
Petrolatum (UNII: 4T6H12BN9U)
Polysorbate 20 (UNII: 7T1F30V5YH)
Water (UNII: 059QF0KO0R)
Shea Butter (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-079-01	1 in 1 CARTON	05/29/2020
1		56.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	05/29/2020

Labeler - GOODSENSE (076059836)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(50804-079)