CMC SHIELD SKIN PROTECTANT- zinc oxide cream 
SKYLARK CMC 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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CMC-SHIELD

ACTIVE INGREDIENT

Zinc Oxide (3.8%)

PURPOSE

Skin Protectant

USES

WARNINGS

For external use only

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

Condition worsens or symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender, methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium, steareth-20, trolamine, vitamin-A, water, FDC Yellow No. 5, DC Red No.21

PACKAGE LABEL

PRINCIPAL DISPLAYDRUG FACT PANEL

CMC SHIELD SKIN PROTECTANT 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71168-3066
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TROLAMINE (UNII: 9O3K93S3TK)  
VITAMIN A (UNII: 81G40H8B0T)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CETETH-10 (UNII: LF9X1PN3XJ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71168-3066-499.2 g in 1 TUBE; Type 0: Not a Combination Product09/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2017
Labeler - SKYLARK CMC PRIVATE LIMITED (650174824)

Revised: 9/2017
Document Id: 58fffc68-579f-0dfc-e053-2991aa0afb27
Set id: 58fffc68-579e-0dfc-e053-2991aa0afb27
Version: 1
Effective Time: 20170912
 
SKYLARK CMC PRIVATE LIMITED