DRS. DIAPER RASH MAXIMUM STRENGTH- zinc oxide cream

Drs. DIAPER RASH MAXIMUM STRENGTH by

Drug Labeling and Warnings

Drs. DIAPER RASH MAXIMUM STRENGTH by is a Otc medication manufactured, distributed, or labeled by OL PHARMA TECH, LLC Drs PHARMACY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 10%

Dimethicone 1 %

Stop using this product and ask a doctor

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

Uses

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

Warning

• For external use only
• when using this product, do not get it into the eye

questions

www.drspharmacyusa.com

KEEP OUT OF REACH OF CHILDREN

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 cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

STORAGE AND HANDLING

store between 20°C to 25 °C ( 68° to 77°F)

Inactive Ingredients

cod liver oil ( contains vitamin A & Vitamin D), propylene glycol, vitamin E, methylparaben, propylparaben, stearic acid, trolamine, ceteareth 20, cetostearyl alcohol, EDTA, mineral oil

purpose

diaper rash cream

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRS. DIAPER RASH MAXIMUM STRENGTH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80489-576
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COD LIVER OIL (UNII: BBL281NWFG)
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TROLAMINE (UNII: 9O3K93S3TK)
MINERAL OIL (UNII: T5L8T28FGP)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80489-576-01	1 in 1 CARTON	02/01/2022
1		20 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 80489-576-02	1 in 1 CARTON	02/01/2022
2		45 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 80489-576-03	1 in 1 CARTON	04/13/2024
3		49.6 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 Drug	M016	10/07/2021

Labeler - OL PHARMA TECH, LLC Drs PHARMACY (021170377)

Registrant - OL PHARMA TECH, LLC Drs PHARMACY (021170377)

Establishment
Name	Address	ID/FEI	Business Operations
OL PHARMA TECH, LLC Drs PHARMACY		021170377	manufacture(80489-576)