THERA DIMETHICONE BODY SHIELD - dimethicone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Available from:

McKesson Medical-Surgical Inc.

INN (International Name):

DIMETHICONE

Composition:

DIMETHICONE 50 uL in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- For the treatment and/or prevention of diaper rash - Temporarily protects and helps relieve chapped or cracked skin

Authorization status:

OTC monograph final

Summary of Product characteristics

THERA DIMETHICONE BODY SHIELD - DIMETHICONE CREAM
MCKESSON MEDICAL-SURGICAL 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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Dimethicone 5.0%
PURPOS E
Skin Protectant
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
US ES
For the treatment and/or prevention of diaper rash
Temporarily protects and helps relieve chapped or cracked skin
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE ON
deep or puncture wounds
animal bites
serious burns
WHEN USING THIS PRODUCT
do not get into eyes
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms last more than 7 days or clear up and occur again within a
few days
DIRECTIONS
Cleanse skin with THERA
Moisturizing Body Cleanser or THERA
Foaming Body Cleanser
Apply cream liberally until entire area is covered
Apply as needed
OTHER INFORMATION
Protect from freezing. Avoid excessive heat.
TM
TM
INACTIVE INGREDIENTS
Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Lead Juice,
SAFFLEX
(Consisting
of: Calcium Pantothenate (Vitamin B ), Maltodextrin, Niacinamide
(Vitamin B ), Pyridoxine HCl
(Vitamin B ), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium
Starch Octenylsuccinate,
Tocopheryl Acetate (Vitamin E)), Bisabolol, Butylene Glycol, Caprylyl
Glycol, Carthamus Tinctorius
(Safflower) Oleosomes, Carthamus Tintorius (Safflower) Seed Oil, Cetyl
Alcohol, Chlorphenesin,
Dimethicone Crosspolymer, Disodium EDTA, Glycerin, Glyceryl Stearate,
Lavender Ylang Fragrance,
PEG-100 Stearate, Pentaery Tetra-di-t-Butyl Hydroxyhydrocinnamate,
Phenoxyethanol, Purified Water,
Sodium Hyaluronate, Stearic Acid, Triethanolamine, Zingiber (Ginger)
Root Extract.
LABEL
TM
5
3
6
THERA DIMETHICONE BODY SHIELD
dimethicone cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 59 9 -0 20 3
ROUTE OF ADMINISTRATION
TOPICA