TENA- dimethicone moisturizing lotion cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SCA Personal Care Inc.

INN (International Name):

DIMETHICONE

Composition:

DIMETHICONE .01 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Skin Protectant Uses •temporarily protects and helps prevent and relieve chafed, chapped, or cracked skin •moisturizes and nourishes normal to dry skin to keep the skin feeling smooth and soft

Authorization status:

OTC monograph final

Summary of Product characteristics

TENA- DIMETHICONE MOISTURIZING LOTION CREAM
SCA PERSONAL CARE 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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DRUG FACTS
ACTIVE INGREDIENT
Dimethicone 1%
PURPOS E
Skin Protectant
US ES
•temporarily protects and helps prevent and relieve chafed, chapped,
or cracked skin
•moisturizes and nourishes normal to dry skin to keep the skin
feeling smooth and soft
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT USE •on deep or puncture wounds •on animal bites •on
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
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a
Poison Control Center immediately.
DIRECTIONS
•apply as needed
OTHER INFORMATION Store between 32° F and 85° F
INACTIVE INGREDIENTS: Water, Dicaprylyl Carbonate, Glycerin, PEG-8
Beeswax, Cetyl Alcohol, Glyceryl Stearate SE, Caprylic/Capric
Triglyceride, Sodium
Citrate, Ceteth-20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
Sorbitan
Caprylate, Phenoxyethanol, Jojoba Esters, Sodium Benzoate,
Steareth-20,
Helianthus Annus (Sunflower) Seed Wax, Citric Acid,
Ethylhexylglycerin, Sodium
Gluconate, Xantham Gum, Acacia Decurrens Flower Wax, Polyglycerin-3,
Tocopherol
QUESTIONS OR COMMENTS?
Call 1-800-992-9939 or visit www.tena.us
TENA
dimethicone moisturizing lotion cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:59 6 0 8 -0 0 2
ROUTE OF ADMINISTRATION
TOPICAL
SCA Personal Care Inc.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)
DIMETHICONE
.0 1 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)
GLYCERIN (UNII: PDC6 A3C0 OX)