EXTRA STRENGTH MEDICATED BODY- dimethicone lotion

Extra Strength Medicated Body by

Drug Labeling and Warnings

Extra Strength Medicated Body by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc, Vi Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

*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.

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH MEDICATED BODY  
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-386
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5.0 kg  in 100 kg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-386-41	.369 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/01/1992

Labeler - CVS Pharmacy, Inc (062312574)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(59779-386)