GALENTIC HYDROGEL- glycerin gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)

Available from:

Galentic Pharma (India) Private Limited

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant Temporarily protects minor - Cuts - Scrapes - Burns

Authorization status:

OTC monograph final

Summary of Product characteristics

GALENTIC HYDROGEL- GLYCERIN GEL
GALENTIC PHARMA (INDIA) PRIVATE LIMITED
_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._
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GALENTIC'S MOISTURIZING WOUND HYDROGEL
ACTIVE INGREDIENT
Glycerin 20.0%
PURPOS E
Skin Protectant
• USES
Temporarily protects minor
Cuts
Scrapes
Burns
• WARNINGS
FOR EXTERNAL USE ONLY
• DO NOT USE ON
Deep or puncture wounds
Animal bites
Serious burns
• WHEN USING THIS PRODUCT
Do not get into eyes
• STOP USE AND ASK A DOCTOR IF
Condition worsens
Symptoms last more than 7 days or clear up and occur again a few days
• KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
• DIRECTIONS
Apply as needed.
Children under 6 months: Ask a doctor
• OTHER INFORMATION
Store at room temperature
• INACTIVE INGREDIENT
Allantoin, Aloe Barbadensis gel, Diazolidinyl urea, Methylparaben,
PEG-4 Olivate, PEG-60
Hydrogenated castor oil, Propylene glycol, Propylparaben, Purified
water, Sodium polyacrylate,
Tetrasodium EDTA, Tocopheryl acetate
Manufactured by : GALENTIC PHARMA (INDIA) PVT. LTD., Plot No. 5-B &
5-C,
Sector III, Kandla Special Economic Zone, Gandhidham-370 230, Gujrat.
India
PRINCIPAL DISPLAY PANEL - 84.7 G TUBE LABEL
_GALENTIC'S_
_MOISTURIZING WOUND HYDROGEL_
GALENTIC
NET WT. 3 OZ. (84.7 G)
_WITH VITAMIN E & ALOE VERA_
_CLEAN AND GREASELESS_
GALENTIC HYDROGEL
glycerin gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 38 2-0 13
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
Galentic Pharma (India) Private Limited
GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)
GLYCERIN
20 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ALLANTO IN (UNII: 344S277G0 Z)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8 C7H