Drug Facts566

Drug Facts566

Drug Labeling and Warnings

Drug Details

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EXTRA STRENGTH MEDICATED BODY - dimethicone lotion 
CVS Pharmacy, 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
566

Active ingredients

Dimethicone 5.0%
Menthol 0.5%

Purpose

Skin protectant
Anti itch

Uses

temporarily relieves itching associated with
minor skin irritation minor burns rashes due to poison ivy, oak or sumac insect bites sunburn
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 tan 7 days or clear up and occur again within  a few days

if redness, irritation, or swelling or pain persists or increases

Keep out of reach of children.

If swallowed, get medical help or contact a Poison control Center right away.

Directions

adults and children 2 years and older: apply freely to affected areal and 3 or 4 times daily
children under 2 years: consult a doctor

Inactive ingredients

water, glycerin, petrolatum, emulsifying wax, stearamidopropyl PG-dimonium chloride phosphate, aloe barbadensis leaf juice, cetyl alcohol, stearyl alcohol, distearyldimonium chloride, propylene glycol, steareth-21, steareth-2, tocopheryl acetate, disodium EDTA, imidazolidinyl urea, propylparaben, methylparaben, triethanolamine, fragrance

*This product is not manufactured or distributed by Chattem, Inc, distributor of Gold Bond Medicated Body Lotion Extra Strength.

CVS/pharmacy Extra Strength Medicated body Lotion is
enriched with soothing aloe and vitamin E to relieve itchy skin more effectively than a typical body lotion. The cooling formula delivers intense moisture and protects dry, chapped skin.

CVS pharmacy
NEW extra strength body lotion
Medicated
Anti-itch/Skin Protectant
Multi-action relief for extra dry, itchy skin
Moisturizes + soothes irritated skin
Relieves +protects
With aloe + Vitamin E
Compare to Gold Bond Medicated Body Lotion Extra Strength
NET WT 14 oz (396 g)

image of principal display panel

EXTRA STRENGTH MEDICATED BODY  
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59779-386
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5.0 kg  in 100 kg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 kg  in 100 kg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARETH-2 (UNII: V56DFE46J5)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59779-386-41.369 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/1992
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/1992
Labeler - CVS Pharmacy, Inc (062312574)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture(59779-386)

Revised: 11/2019
 
CVS Pharmacy, Inc


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