HYDRA C3 TRIPLE RESET- witch hazel cream 
ULAB

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 INGREDIENT

Active ingredients: WITCH HAZEL 5.0%

INACTIVE INGREDIENT

Inactive ingredients: Aqua (WATER), Glycerin (and) Glyceryl Polyacrylate, Bifida Ferment Lysate, Glycerin, Propylene Glycol, Phenoxyethanol, Carbomer, Triethanolamine, Olive Glycerides, Ceramide 3, Fragrance, Mica, CI 77891, Silica, Ethylhexylglycerin, CI 77491, Tin oxide

PURPOSE

Purpose: Skin nourishing and strengthening

WARNINGS

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: Apply morning and night

DOSAGE & ADMINISTRATION

Dosage & Administration: Apply morning and night to face and neck after serum and ampoule

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

HYDRA C3 TRIPLE RESET 
witch hazel cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71276-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL3.0 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71276-100-021 in 1 CARTON03/02/2017
1NDC:71276-100-0160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/02/2017
Labeler - ULAB (688976692)
Registrant - ULAB (688976692)
Establishment
NameAddressID/FEIBusiness Operations
ULAB688976692relabel(71276-100)
Establishment
NameAddressID/FEIBusiness Operations
U-LAB Switzerland AG485958743manufacture(71276-100)

Revised: 3/2017
Document Id: f8a723fb-dfb4-49ad-b52d-0f812825214e
Set id: 74476689-b618-4d7a-a82a-5bc0357ea32c
Version: 1
Effective Time: 20170322
 
ULAB