Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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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%

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

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, Fragrance,

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

image description

TENA 
dimethicone moisturizing lotion cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59608-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE.01 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
GLYCERIN (UNII: PDC6A3C0OX)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CETETH-20 (UNII: I835H2IHHX)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
SORBITAN (UNII: 6O92ICV9RU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARETH-20 (UNII: L0Q8IK9E08)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59608-004-10100 mL in 1 TUBE; Type 0: Not a Combination Product05/28/2017
2NDC: 59608-004-25250 mL in 1 TUBE; Type 0: Not a Combination Product05/28/2017
3NDC: 59608-004-055 mL in 1 TUBE; Type 0: Not a Combination Product05/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/28/2017
Labeler - SCA Personal Care Inc. (790100549)

Revised: 7/2017
 
SCA Personal Care Inc.


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