CALGONATE CALCIUM GLUCONATE GEL 2.5%- calcium gluconate gel

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

CALCIUM GLUCONATE (UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB)

Disponível em:

Denison Pharmaceuticals, LLC

Via de administração:

TOPICAL

Tipo de prescrição:

OTC DRUG

Indicações terapêuticas:

Purpose First aid response to hydrofluorix acid (HF) exposure Intended Use: Topical skin treatment for hydrofuoric acid burns or exposure.

Status de autorização:

unapproved drug other

Características técnicas

CALGONATE CALCIUM GLUCONATE GEL 2.5%- CALCIUM GLUCONATE GEL
DENISON PHARMACEUTICALS, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
CALGONATE
_ACTIVE INGREDIENTS_
Calcium Gluconate, 2.5%
KEEP OUT OF REACH OF CHILDREN. For external use only. Avoid contact
with eyes.
PURPOS E
First aid response to hydrofluorix acid (HF) exposure
DIRECTIONS
Before applying gel, rinse area with water. Invert cap and pierce
metal seal to open tube. Apply gel
freely, massage in. Reapply gel every 10 to 15 minutes while seeking
emergency medical assistance.
INACTIVE INGREDIENTS
Purified water, Cabapol 934 Polymer, Methylparaben, Sodium Hydroxide
INTENDED USE:
Topical skin treatment for hydrofuoric acid burns or exposure.
WARNINGS
Do not use if tube is damaged or open.
Re-use risks: contamination, low product efficacy.
Denison Pharmaceuticals, LLC
CALGONATE CALCIUM GLUCONATE GEL 2.5%
calcium gluconate gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 29 5-7520
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CALCIUM GLUCO NATE (UNII: SQE6 VB453K) (CALCIUM CATION - UNII:2M8
3C4R6 ZB)
CALCIUM GLUCONATE
2.5 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )
METHYLPARABEN (UNII: A2I8 C7HI9 T)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:0 29 5-7520 -40
25 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 3/26 /20 19
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
0 3/26 /20 19
LABELER -
Denison Pharmaceuticals, LLC (001207208)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Deniso n Pharmaceuticals, LLC
0 0 120 720 8
ma nufa c