Essity (as PLD) - TENA PROSKIN BODY LOTION (59608-009)

TENA PROSKIN FRAGRANCE-FREE BODY by

Drug Labeling and Warnings

TENA PROSKIN FRAGRANCE-FREE BODY by is a Otc medication manufactured, distributed, or labeled by ESSITY HMS NORTH AMERICA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TENA PROSKIN FRAGRANCE-FREE BODY- dimethicone lotion 
ESSITY HMS NORTH AMERICA 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.

----------

Essity (as PLD) - TENA PROSKIN BODY LOTION (59608-009)

ACTIVE INGREDIENT

DIMETHICONE 1.1%

PURPOSE

SKIN PROTECTANT

USES

• TEMPORARILY PROTECTS AND HELPS PREVENT AND RELIEVE CHAFED, CHAPPED, OR CRACKED SKIN.

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 AGAINWITHIN 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, PEG-8 BEESWAX, CETYL ALCOHOL, GLYCERYL STEARATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM CITRATE, CETETH-20, ACRYLATES C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM CAPRYLATE, PHENOXYETHANOL, JOJOBA ESTERS, SODIUM BENZOATE, STEARETH-20, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, CITRIC ACID, ETHYLHEXYLGLYCERIN, SODIUM GLUCONATE, XANTHAN GUM, ACACIA DECURRENS FLOWER WAX, POLYGLYCERIN-3, TOCOPHEROL

QUESTIONS OR COMMENTS?

CALL 1-866-275-8362 OR VISIT WWW.TENA.US

TENA CONSUMER CARE CENTER

P.O. BOX 8091

EAU CLAIRE, WI 54702-8091

TENA PROSKIN FRAGRANCE-FREE BODY 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59608-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CETETH-20 (UNII: I835H2IHHX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARETH-20 (UNII: L0Q8IK9E08)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) (UNII: AS2SZ9757N)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59608-009-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/31/2021

Labeler - ESSITY HMS NORTH AMERICA INC (787850148)

Revised: 2/2022

Document Id: d6fa3422-beaf-0772-e053-2995a90a4920

34390-5

Set id: d60ee279-1a76-7448-e053-2995a90a6de1

Version: 3

Effective Time: 20220201