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NDC 70512-0103-30 Zinc Oxide 20% 200 mg/g Details

Zinc Oxide 20% 200 mg/g

Zinc Oxide 20% is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by SOLA Pharmaceuticals. The primary component is ZINC OXIDE.

Product Information

NDC	70512-0103
Product ID	70512-103_e314cc52-3f75-9a9c-e053-2a95a90a3f4a
Associated GPIs	90971020004210
GCN Sequence Number	005576
GCN Sequence Number Description	zinc oxide OINT. (G) 20 % TOPICAL
HIC3	L3A
HIC3 Description	PROTECTIVES
GCN	22080
HICL Sequence Number	002361
HICL Sequence Number Description	ZINC OXIDE
Brand/Generic	Generic
Proprietary Name	Zinc Oxide 20%
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide 20%
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	200
Active Ingredient Units	mg/g
Substance Name	ZINC OXIDE
Labeler Name	SOLA Pharmaceuticals
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70512-0103-30 (70512010330)

Pricing Information	N/A
NDC Package Code	70512-103-30
Billing NDC	70512010330
Package	1 TUBE in 1 CARTON (70512-103-30) / 28.4 g in 1 TUBE
Marketing Start Date	2021-04-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c091d3ed-f317-9193-e053-2a95a90a4917 Details

Active Ingredient

Zinc Oxide 20%

Purpose

Skin protectant

Uses

Skin Protectant

Helps treat and prevent diaper rash
Dries the ozzing and weeping of poison: •Ivy •Oak •Sumac

Warnings

For external use only

When using this product

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

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help

Directions

For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply paste liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
For poison ivy, oak, and sumac: Apply as needed

Other Information

Store at room temperature
Avoid excessive heat and humidity

Inactive ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Mineral oil, Petrolatum

PRINCIPAL DISPLAY PANEL

Questions of comments? Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals

Baton Rouge, LA 70810

Store at room temperature. Avoid excessive heat and humidity.

Zinc Oxide 20% Ointment

NDC 70512-103-30

Qty: 28.4g

INGREDIENTS AND APPEARANCE

ZINC OXIDE 20%

zinc oxide 20% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70512-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CETETH-20 (UNII: I835H2IHHX)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70512-103-30	1 in 1 CARTON	04/22/2021
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/22/2021

Labeler - SOLA Pharmaceuticals (080121345)

Revised: 7/2022

Document Id: e314cc52-3f75-9a9c-e053-2a95a90a3f4a

Set id: c091d3ed-f317-9193-e053-2a95a90a4917

Version: 3

Effective Time: 20220705