AHC HYDRA B5 SOOTHER

Drug Labeling and Warnings

Drug Details [pdf]

AHC HYDRA B5 SOOTHER- panthenol liquid 
Carver Korea Co.,Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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AHC HYDRA B5 SOOTHER

Active Ingredients

Panthenol (1%)

Purpose

Skin Protectant

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

Moisturizes skin.

Warnings

For external use only


Do not use when skin is red, inflamed, irritated, or painful


When using this product

  • do not apply on other parts of the body
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
  • do not apply directly to wound or open cut

Stop use and ask a doctor if

  • Rash or irritation on skin develops and lasts

Directions

Apply the adequate amount on skin evenly.

Inactive Ingredients

WATER, GLYCERIN, BUTYLENE GLYCOL, 1,2-HEXANEDIOL, PORTULACA OLERACEA EXTRACT, SODIUM HYALURONATE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, BETULA PLATYPHYLLA JAPONICA JUICE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, NATTO GUM, PHENOXYETHANOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AHC HYDRA B5 SOOTHER 
panthenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58930-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) Panthenol0.5 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PURSLANE (UNII: M6S840WXG5)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58930-102-021 in 1 PACKAGE05/12/201712/01/2018
1NDC: 58930-102-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/12/201712/01/2018
Labeler - Carver Korea Co.,Ltd. (688442290)
Registrant - Carver Korea Co.,Ltd. (688442290)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(58930-102)

Revised: 5/2019
Document Id: ff1d8992-a1b9-4c91-87c3-caf8032ea9c6
Set id: 6d83f818-6a2d-45e4-a69b-32a6bfa67a87
Version: 4
Effective Time: 20190517
 
Carver Korea Co.,Ltd.