ZINC OXIDE- zinc oxide ointment 
Delsam Pharma Llc

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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ZINC OXIDE OINTMENT USP 20%

Drug Facts

Active ingredient

Zinc oxide USP 20%

Purpose

Skin protectant

Uses

• helps treat and prevent diaper rash  • dries the oozing and weeping of:  • poison ivy  • poison oak  • poison sumac

Warnings

For external use only

When using this product  • avoid contact with eyes

Stop use and ask a doctor if  • conditions 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.

Directions

For diaper rash

• change wet and soiled diapers promptly, allow to dry

• apply ointment liberally with each diaper change especially at bedtime or anytime when exposure to wet diapers may be prolonged

To dry the oozing and weeping of poison ivy, poison oak, or poison sumac

• apply ointment liberally as often as needed.

Inactive ingredients

Mineral Oil, White Petroleum Jelly

Other information

• do not use if seal is punctured or is not visible  • use cap to puncture seal  • store at room temperature  • do not exceed 30°C (86°F)

Questions or comments?

1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

Zinc109

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72570-109-301 in 1 CARTON09/25/201803/15/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/25/201803/15/2023
Labeler - Delsam Pharma Llc (081369679)

Revised: 3/2023
 
Delsam Pharma Llc