BIOELEMENTS IMMEDIATE COMFORT- hydrocortisone acetate lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Bioelements, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

BIOELEMENTS IMMEDIATE COMFORT- 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.
BIOELEMENTS IMMEDIATE COMFORT
hydrocortisone acetate lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:49 8 25-126
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -
UNII:WI4X0 X7BPJ)
HYDROCORTISONE
ACETATE
0 .0 8 8 mL
in 8 8 mL
Bioelements, Inc.
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)
ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)
CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED)
(UNII: 4Q9 3RCW27E)
GLYCERYL MO NO S