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NDC 68196-0002-06 Members Mark Diaper Rash 13 g/100g Details

Members Mark Diaper Rash 13 g/100g

Members Mark Diaper Rash is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Sams West Inc. The primary component is ZINC OXIDE.

Product Information

NDC	68196-0002
Product ID	68196-002_bc083286-4393-46c8-ab75-04701d48f6c6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Members Mark Diaper Rash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	13
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	Sams West Inc
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 68196-0002-06 (68196000206)

Pricing Information	N/A
NDC Package Code	68196-002-06
Billing NDC	68196000206
Package	170 g in 1 TUBE (68196-002-06)
Marketing Start Date	2017-08-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e656c7e7-5de4-4e3c-b714-bec2dd63a852 Details

Active ingredient

Zinc Oxide 13%

Purpose

Skin protectant

Uses

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

Warnings

For external use only.

When using this product

Do not get into eyes.

Stop using this product and ask a doctor if

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

Do not use on

deep puncture wounds
animal bites
serious burns

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

change wet and soiled diapers promptly
clean the diaper area and allow to dry
apply ointment liberally as often as required with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other information

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

Inactive ingredients

Water (Aqua), Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Aloe Barbadensis Leaf Juice, Glycerin, Tropolone, Tocopheryl Acetate, Panthenol, 1,2-Hexanediol, Caprylyl Glycol, Magnesium Sulfate, Potassium Hydroxide.

Questions or comments?

1-888-301-0332

Label copy

INGREDIENTS AND APPEARANCE

MEMBERS MARK DIAPER RASH

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68196-002
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
TROPOLONE (UNII: 7L6DL16P1T)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PANTHENOL (UNII: WV9CM0O67Z)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68196-002-07	170 g in 1 TUBE; Type 0: Not a Combination Product	03/20/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/20/2018

Labeler - Sams West Inc (051957769)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(68196-002)

Revised: 3/2018

Document Id: bc083286-4393-46c8-ab75-04701d48f6c6

Set id: e656c7e7-5de4-4e3c-b714-bec2dd63a852

Version: 1

Effective Time: 20180321