Label: ITCH RELIEF- diphenhydramine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68421-8300-0 - Packager: Cintas First Aid & Safety
- Category: HUMAN OTC DRUG LABEL
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 May 13, 2013
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses:
- Warnings
- Directions:
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ITCH RELIEF
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68421-8300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) diphenhydramine hydrochloride 20.3 g in 1 L Inactive Ingredients Ingredient Name Strength diazolidinyl urea (UNII: H5RIZ3MPW4) edetate disodium (UNII: 7FLD91C86K) glycerin (UNII: PDC6A3C0OX) C12-15 PARETH-9 (UNII: H3ZIY6WP1R) water (UNII: 059QF0KO0R) trolamine (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68421-8300-0 0.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/13/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/13/2013 Labeler - Cintas First Aid & Safety (056481716) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(68421-8300)