S-CREAM ZINC OXIDE 13%- zinc oxide cream
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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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S-Cream ZINC OXIDE 13% SKIN PROTECTANT CREAM

Drug Facts

ACTIVE INGREDIENT

Zinc Oxide 13%

PURPOSE

Skin Protectant

INACTIVE INGREDIENTS

Water, Mineral oil, Petrolatum, Beeswax, Dimethicone, Sorbitan sesquioleate, Microcrystalline wax, PEG-30 Dipolyhydroxystearate, Aloe barbadensis leaf extract, Glycerin, Tropolone, Tocopheryl acetate, 1,2-Hexanediol, Caprylyl glycol, Magnesium sulfate, Potassium hydroxide, Phenoxyethanol

USES

• Helps treat and prevent diaper rash

• Protects chafed skin due to diaper rash and helps seal out moisture • Insect bites • Burns minor abrasions • Skin irritation

WARNINGS

For external use only

When using this product
Do not get into 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

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
• 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

OTHER INFORMATION

store at 20° to 25°C (68°F to 77°F)
Protect from freezing
May stain clothing

Questions or comments?

1-800-572-6632 between 9am and 4pm EST, Monday-Friday.

SKIN PROTECTANT CREAM

Effectively Treats & Prevents:
√ Skin irritation √ Diaper rash
√ Burns √ Cuts / Abrasions

Manufactured by:

Global pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

Zincoxide13-1

S-CREAM ZINC OXIDE 13%
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73921-013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	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 (4000 MW) (UNII: 9713Q0S7FO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
TROPOLONE (UNII: 7L6DL16P1T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73921-013-30	1 in 1 CARTON	04/01/2021	02/08/2023
1		30 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	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Name	Address	ID/FEI	Business Operations
Establishment
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-013)

Revised: 2/2023

Document Id: f42b2912-248a-7619-e053-2a95a90ae1ba

Set id: f8aa5f9e-c616-4246-924e-15320ece1063

Version: 2

Effective Time: 20230208

GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED