MEMBERS MARK DIAPER RASH- zinc oxide cream

Members Mark Diaper Rash by

Drug Labeling and Warnings

Members Mark Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Sams West Inc, Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Sams West Inc (051957769)

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

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