Your browser does not support JavaScript! PERSONAL CARE (MEDICATED BODY POWDER) POWDER [PERSONAL CARE PRODUCTS, INC.]
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PERSONAL CARE (medicated body powder) powder
[Personal Care Products, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredients                                      Purpose
Menthol 0.15 percent                   External analgesic
Zinc Oxide 1.0 percent                     Skin protectant

Uses     for the temporary relief of the pain and itch associated with:
- minor cuts - scrapes - sunburn - insect bites - prickly heat - rashes
- minor burns - minor skin irritation - dries the oozing of poison ivy, oak
and sumac.

Warnings
For external use only
When using this product avoid contact with eyes.

Stop using and ask a doctor if
- condition worsens 
- symptoms do not get better within 7 days or clear up and occur again within a few days

Keep out of reach of children. In case of accidental ingestion, get medical help or
contact a Poison Control Center right away.

Directions
adults and children 2 years and older, apply freely up to 3 or 4 times daily
- under 2 years: ask a doctor before using
- for best results, dry skin thoroughly before use.

Inactive ingredients
talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate

Personal Care Medicated Body Powder

PERSONAL CARE 
medicated body powder powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:29500-9090
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol3 mg  in 2 g
Zinc Oxide (Zinc Cation) Zinc Oxide20 mg  in 2 g
Inactive Ingredients
Ingredient NameStrength
Talc 
Acacia 
Eucalyptol 
Methyl Salicylate 
Salicylic Acid 
Thymol 
Zinc Stearate 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-9090-1283 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2009
Labeler - Personal Care Products, Inc. (603124298)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture

Revised: 9/2009
 
Personal Care Products, Inc.

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