IMMEDIATE COMFORT BIOELEMENTS- hydrocortisone acetate lotion 
Bioelements, Inc.

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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Immediate Comfort

Active Ingredient Purpose

Hydrocortisone Acetate 1% Anti-itch lotion

Uses

For the temporary relief of itching associated with minor skin irritations and rashes due to exzema, detergents, cosmetics, jewelry, dermatitis, psoriasis.

Other uses of this product should be only under the advice and supervision of a doctor.

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Warnings

For external use only

When using this product avoid contact with the eyes.

Directions

Apply to affected area no more than 3 to 4 times daily.

Inactive ingredients

Butylene Glycol, C12-15 Alkyl Benzoate, Carbomer, Glyceryl Stearate, Helianthuus annus (sunflower) Seed Oil, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Ploysorbate 80, Sodium Hydroxide, Sorbitol, Tocopheryl Acetate, Water (Aqua, Eau)

Bioelements PROFESSIONAL-USE-ONLY

Immediate comfort

1% Hydrocortisone Acetate Lotion

88 ml/ 3 Fl Oz.

bottle label

IMMEDIATE COMFORT  BIOELEMENTS
hydrocortisone acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-134
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 88 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL (UNII: 506T60A25R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49825-134-0188 mL in 1 BOTTLE; Type 0: Not a Combination Product08/23/201203/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/23/201203/26/2020
Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Dhaliwal Labs016754201manufacture(49825-134)

Revised: 10/2021
Document Id: cd52a786-8833-13c5-e053-2a95a90a430e
Set id: b16fc56a-8036-4050-9c47-75ef1b4b452d
Version: 7
Effective Time: 20211001
 
Bioelements, Inc.