HAND SANITIZER ALCOHOL 75%- alcohol gel 
Frog Prince (Fujian) Baby & Child Care Products Co., Ltd.

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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DR. PALM HAND SANITIZER - ALCOHOL 75% - ANTISEPTIC SOLUTION

ACTIVE INGREDIENT

ALCOHOL 75%

PURPOSE

ANTISEPTIC

USE

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

WARNINGS

FOR EXTERNAL USE ONLY.

KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE

WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY AT 1-800-222-1222.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF EXTRACT, AMINOMETHYL PROPANOL, BUTYLENE GLYCOL, GLYCERIN, WATER (AQUA).

01b LBL_FPB_Dr Palm_Hand Sani_30mL_PDP

01b LBL_FPB_Dr Palm_Hand Sani_30mL_DF1

01b LBL_FPB_Dr Palm_Hand Sani_30mL_DF2

HAND SANITIZER  ALCOHOL 75%
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81886-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ALOE VERA FLOWER (UNII: 575DY8C1ER)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81886-101-1130 mL in 1 PACKET; Type 0: Not a Combination Product05/12/2021
2NDC:81886-101-1227 mL in 1 PACKET; Type 0: Not a Combination Product05/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/12/2021
Labeler - Frog Prince (Fujian) Baby & Child Care Products Co., Ltd. (416772555)
Establishment
NameAddressID/FEIBusiness Operations
Frog Prince (Fujian) Baby & Child Care Products Co., Ltd.416772555manufacture(81886-101)

Revised: 5/2021
Document Id: c5a97abd-c72a-4d90-8b2a-b35db79f39df
Set id: 0116356c-f280-4561-b1fe-14b087048af3
Version: 2
Effective Time: 20210513
 
Frog Prince (Fujian) Baby & Child Care Products Co., Ltd.