SPAI-SONS FINE TALCUM: Package Insert and Label Information

SPAI-SONS FINE TALCUM- talc and zinc oxide powder
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

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.

The active ingredient are Talc and Zinc Oxide

This product is used to keep cool moist areas of the body as the feet and armpits, and retain moisture from them.

Keep out of reach of children this product

Use the product in the feet after the shower

Do not take this product is only for topical application. If swallowed consult your doctor.

This product is for topical application, apply a moderate amount desired area.

Inactive ingredients not produce irritation or healt effects.

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IMAGE OF THE LABEL
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IMAGE OF THE LABEL
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SPAI-SONS FINE TALCUM
talc powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66854-018
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TALC (TALC) TALC 81 g in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM CARBONATE
STARCH, CORN
BORIC ACID
Product Characteristics
Color white (WHITE) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66854-018-01 150 g in 1 BOTTLE None
2 NDC:66854-018-02 250 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part347 06/30/2012
Labeler — SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Registrant — SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Establishment
Name Address ID/FEI Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS 880172184 analysis, manufacture, label, pack

Revised: 06/2012 SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

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