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Name:Body Essence Raspberry Antibacterial
Manufacturer:Puretek Corporation
Category:Over-the-counter (OTC) Marketed Drugs


BODY ESSENCE RASPBERRY ANTIBACTERIAL   - triclosan lotion 
PureTek Corporation

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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Triclosan 0.17%

Antibacterial moisturizing hand lotion.

Caution: Keep out of reach of children. For external use only. If swallowed, get medical help or contact a Poison Control Center immediately.

Helps kill germs and keep them away.

Do not use on or near eyes. In case of contact, rinse eyes thoroughly with water. If irritation or redness develops, discontinue use.

Directions: Dispense lotion onto hands and rub into skin until absorbed.

INACTIVE INGREDIENTS: PURIFIED WATER, STEARIC ACID, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, CETYL ALCOHOL, C12-15 ALKYL ETHYLHEXANOATE, DIMETHICONE, MENTHYL LACTATE, RETINYL PALMITATE (VITAMIN A), TOCOPHERYL ACETATE (VITAMIN E), PANTHENOL (PROVITAMIN B5), CAMELLIA OLEIFERA SEED EXTRACT (WHITE TEA AND OOLONG TEA), CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, TRITICUM VULGARE (WHEAT) GERM OIL, HYDROLYZED SILK, LACTOSE, LAURETH-7, GLYCERYL STEARATE, PEG-100 STEARATE, CETYL PHOSPHATE, HYDROXYPROPYL METHYLCELLULOSE, BUTYLENE GLYCOL, C13-14 ISOPARAFFIN, NYLON-12, POLYACRYLAMIDE, CARBOMER, BHT, TRIETHANOLAMINE, PHENOXYETHANOL, BUTYLPARABEN, ETHYLPARABEN, ISOBUTYLPARABEN, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE, RED 4 (CI 14700), ULTRAMARINES (CI 77007), XANTHAN GUM, YELLOW 6 (CI 15985).

THIS PRODUCT CONTAINS NATURAL INGREDIENTS, WHICH MAY CAUSE COLOR VARIATION.

image of label


BODY ESSENCE RASPBERRY ANTIBACTERIAL  
triclosan lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-740
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 1.7 uL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
STEARIC ACID  
SUNFLOWER OIL  
CETYL ALCOHOL  
DIMETHICONE  
MENTHYL LACTATE  
VITAMIN A PALMITATE  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
PANTHENOL  
CAMELLIA OLEIFERA SEED  
GREEN TEA LEAF  
WHEAT GERM OIL  
LACTOSE  
LAURETH-7  
GLYCERYL MONOSTEARATE  
POLYOXYL 100 STEARATE  
CETYL PHOSPHATE  
HYPROMELLOSES  
BUTYLENE GLYCOL  
C13-14 ISOPARAFFIN  
CARBOMER HOMOPOLYMER TYPE A  
BUTYLATED HYDROXYTOLUENE  
TROLAMINE  
PHENOXYETHANOL  
BUTYLPARABEN  
ETHYLPARABEN  
ISOBUTYLPARABEN  
METHYLPARABEN  
PROPYLPARABEN  
FD&C RED NO. 4  
XANTHAN GUM  
FD&C YELLOW NO. 6  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59088-740-05 59 mL in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 12/28/2009

Labeler - PureTek Corporation (785961046)
Establishment
Name Address ID/FEI Operations
PureTek Corporation 785961046 manufacture, label, pack, outsourcing human drug compounding, relabel, repack
Establishment
Name Address ID/FEI Operations
PureTek Corporation 031678746 manufacture, pack, label, outsourcing human drug compounding, repack, relabel

Revised: 01/2011 PureTek Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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