AQUATION ANTI-CHAFE CREAM- zinc oxide lotion 
RNA PHARMA, LLC

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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active ingredients

indications & usage

dosage & administration

warnings

inactive ingredients

purpose

keep out of reach of children

package label principal

AQUATION ANTI-CHAFE CREAM 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60717-730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENTONITE (UNII: A3N5ZCN45C)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
OATMEAL (UNII: 8PI54V663Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CERAMIDE 2 (UNII: C04977SRJ5)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
SUCROSE DISTEARATE (UNII: 33X4X4B90S)  
CERAMIDE AP (UNII: F1X8L2B00J)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE 4 (UNII: SF3LP91341)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60717-730-041 in 1 BOX12/27/2022
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01612/27/2022
Labeler - RNA PHARMA, LLC (079103999)
Establishment
NameAddressID/FEIBusiness Operations
RNA PHARMA, LLC079103999manufacture(60717-730)

Revised: 12/2022
Document Id: f0d5f671-cced-7a0b-e053-2a95a90a9e01
Set id: f0d5f671-ccec-7a0b-e053-2a95a90a9e01
Version: 1
Effective Time: 20221227
 
RNA PHARMA, LLC