Label: RELIAMED- zinc oxide, calamine dressing
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Contains inactivated NDC Code(s)
NDC Code(s): 52641-300-03, 52641-300-04 - Packager: Reliamed
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 13, 2010
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- Active Ingredients
- Purpose
- Uses
- Warning
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- Other Ingredients
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Principal Display Panel
NDC 52641-300-03
REORDER NO. ZGUBC3
ReliaMed®
UNNA BOOT
DRESSING
With Calamine
VENDA MOLDEABLE DE
APOSITO CON POMADA
Con Calamina
3 in x 10 yds (7.5 cm x 9 m)
Stretched
1 Each/Pieza
3 in
Do not reuse. Single use only.
No vuelva a utilizar. Estos apositos son de un solo uso.
59o - 77o F (15 - 25o C) Store at ambient temperature
59o - 77o F (15 - 25o C) Imacene a temperatura ambiente.
Keep Dry. Do not store in damp conditions.
Mantengase seco. No almacenar bajo condiciones humedas.
Distributed By ReliaMed® Distribuido por ReliaMed®
Ft. Worth, TX 76106 1-800-409-2848
Made in Mexico. Hecho en Mexico
Rev. 03311
NDC 52641-300-04
REORDER NO. ZGUBC4
ReliaMed®
UNNA BOOT
DRESSING
With Calamine
VENDA MOLDEABLE DE
APOSITO CON POMADA
Con Calamina
4 in x 10 yds (10 cm x 9 m)
Stretched
1 Each/Pieza
4 in
Do not reuse. Single use only.
No vuelva a utilizar. Estos apositos son de un solo uso.
59o - 77o F (15 - 25o C) Store at ambient temperature
59o - 77o F (15 - 25o C) Imacene a temperatura ambiente.
Keep Dry. Do not store in damp conditions.
Mantengase seco. No almacenar bajo condiciones humedas.
Distributed By ReliaMed® Distribuido por ReliaMed®
Ft. Worth, TX 76106 1-800-409-2848
Made in Mexico. Hecho en Mexico
Rev. 03311
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INGREDIENTS AND APPEARANCE
RELIAMED
zinc oxide, calamine dressingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52641-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE 25 g FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 0.015 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE 0.985 g Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) CASTOR OIL (UNII: D5340Y2I9G) GLYCERIN (UNII: PDC6A3C0OX) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52641-300-03 1 in 1 BOX 2 NDC:52641-300-04 1 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/13/2010 Labeler - Reliamed (049386139)