Label: PEGO HEAT RASH CARE CREAM (hamamelis virginiana (witch hazel) extract,lonicera japonica (honeysuckle) flower extract,prunus persica (peach)leaf extract,taraxacum officinale- dandelion rhizome/root extract,viola yedoensis extract. cream

  • NDC Code(s): 84509-013-01
  • Packager: Guangzhou Senmai Biotechnology Co.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 9, 2024

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  • Active Ingredients

    Hamamelis Virginiana (Witch Hazel) Extract 5%
    Lonicera Japonica (Honeysuckle) Flower Extract 1%
    Prunus Persica (Peach) Leaf Extract 0.5%
    Taraxacum Officinale (Dandelion) Rhizome/root Extract 0.5%

    Viola Yedoensis Extract 0.5%

  • Purpose

    Anti-inflammatory

    Antibacterial

  • Uses

    Soothing and caring for baby heat rash , Used in combination with other medicines, it can provide better relief and management of baby heat rash.

  • Warnings

    For external use only.

  • Do not use

    on damaged or broken skin.

  • When using this product

    Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children.

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

  • Directions

    Before use, clean and dry the affected area,take an appropriate amount and apply to the affected area of baby's skin,spreading evenly with your fingers.

  • Precautions

    To do an allergy test before use,take a small amount of the Heat Rash Care Cream and apply it to your baby's wrist, wait about 10 minutes to see if there is an allergy, if so stop using.This cream is designed to help relieve heat rash skin problems and is not a treatment for the disease.lf your baby has serious skin problems,breakage,etc., please take your baby to a doctor.

  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • Product Name

    PEGO Heat Rash Care Cream

  • Dosagee

    Approximately 0.05-01 oz each time

  • Inactive Ingredients

    Water, Butylene Glycol,Malva Sylvestris(Mallow) Extract, Corn Starch Modified,Portulaca Oleracea Extract,Opuntia Streptacantha Stem Extract,Paeonia Suffruticosa Root Extract,Chrysanthellum Indicum Extract,Scutellaria Baicalensis Root Extract, Houttuynia Cordata Extract,Hydroxyacetophenone,Saccharide lsomerate,1.2-hexanediol,Ammonium Acryloyldimethyltaurate/vp Copolymer, Menthyl Lactate,Menthyl Pca, Propylene Glycol

  • Manufacturer

    Guangzhou Senmai Biotechnology Co.

  • Address

    20-1second floor, 20-2 first to third floor,Dashan Road,Qinghu,Junhe Street, Baiyun district, Guangzhou City, China.

  • Capacity

    100ml-e-3.38 fl.oz

  • Shelf Life

    3 Years

  • Place of Origin

    Made in China

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PEGO HEAT RASH CARE CREAM 
    hamamelis virginiana (witch hazel) extract,lonicera japonica (honeysuckle) flower extract,prunus persica (peach)leaf extract,taraxacum officinale (dandelion) rhizome/root extract,viola yedoensis extract. cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84509-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV) HAMAMELIS VIRGINIANA LEAF5000 mg  in 100 mL
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) (LONICERA JAPONICA FLOWER - UNII:4465L2WS4Y) LONICERA JAPONICA FLOWER1000 mg  in 100 mL
    PRUNUS PERSICA LEAF (UNII: VN3501T41P) (PRUNUS PERSICA LEAF - UNII:VN3501T41P) PRUNUS PERSICA LEAF500 mg  in 100 mL
    VIOLA PHILIPPICA WHOLE (UNII: O176VC3N54) (VIOLA PHILIPPICA WHOLE - UNII:O176VC3N54) VIOLA PHILIPPICA WHOLE500 mg  in 100 mL
    TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU) (TARAXACUM OFFICINALE ROOT - UNII:9DE5YCO0RU) TARAXACUM OFFICINALE ROOT500 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    METHYL LACTATE, (-)- (UNII: 0379G9C44S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PURSLANE (UNII: M6S840WXG5)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    MENTHYL DL-PYRROLIDONECARBOXYLATE (UNII: 8P18J856U2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    OPUNTIA STREPTACANTHA STEM (UNII: 3TF9Z1U73O)  
    CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
    PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84509-013-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/09/2024
    Labeler - Guangzhou Senmai Biotechnology Co. (707735253)
    Registrant - Dongguan Xiaogoubeige trading company Ltd. (707735253)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongguan Xiaogoubeige trading company Ltd.707735253label(84509-013) , manufacture(84509-013)
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