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

PEGO Heat Rash Care Cream by

Drug Labeling and Warnings

PEGO Heat Rash Care Cream by is a Otc medication manufactured, distributed, or labeled by Guangzhou Senmai Biotechnology Co., Dongguan Xiaogoubeige trading company Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84509-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV)	HAMAMELIS VIRGINIANA LEAF	5000 mg  in 100 mL
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) (LONICERA JAPONICA FLOWER - UNII:4465L2WS4Y)	LONICERA JAPONICA FLOWER	1000 mg  in 100 mL
PRUNUS PERSICA LEAF (UNII: VN3501T41P) (PRUNUS PERSICA LEAF - UNII:VN3501T41P)	PRUNUS PERSICA LEAF	500 mg  in 100 mL
VIOLA PHILIPPICA WHOLE (UNII: O176VC3N54) (VIOLA PHILIPPICA WHOLE - UNII:O176VC3N54)	VIOLA PHILIPPICA WHOLE	500 mg  in 100 mL
TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU) (TARAXACUM OFFICINALE ROOT - UNII:9DE5YCO0RU)	TARAXACUM OFFICINALE ROOT	500 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84509-013-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	09/09/2024

Labeler - Guangzhou Senmai Biotechnology Co. (707735253)

Registrant - Dongguan Xiaogoubeige trading company Ltd. (707735253)

Establishment
Name	Address	ID/FEI	Business Operations
Dongguan Xiaogoubeige trading company Ltd.		707735253	label(84509-013) , manufacture(84509-013)