S-Cream ZINC OXIDE 13% SKIN PROTECTANT CREAM

S-Cream ZINC OXIDE 13% by

Drug Labeling and Warnings

S-Cream ZINC OXIDE 13% by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

----------

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 73921-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73921-013-301 in 1 CARTON04/01/202102/08/2023
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 finalpart34704/01/202102/08/2023
Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
NameAddressID/FEIBusiness Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED860186917manufacture(73921-013)

Revised: 2/2023
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.