SARENE SOOTHING SKIN- allantoin stick

Sarene Soothing Skin by

Drug Labeling and Warnings

Sarene Soothing Skin by is a Otc medication manufactured, distributed, or labeled by Beekley Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredient:

Allantoin 0.5%

Purpose:

Skin Protectant

Uses:

• helps prevent and helps relieve chafed, chapped or cracked skin
  
• temporarily protects minor cuts, scrapes, burns

Warnings

For external use only.

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 within a few days

Do not use on

• deep or puncture wounds
  
• animal bites
  
• serious burns

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply as needed.

Other Information

• Store at 59º – 86º F (15º - 30º C)
  
• may stain some fabrics

Inactive Ingredients

aloe barbadensis (aloe vera) leaf juice, C18-36 acid triglycerides, caprylic/capric triglycerides, tocopheryl acetate, tribehenin

Questions

+1 (800) 233-5539

Distributor:
Beekley Corporation, Bristol, CT
Made in Canada

PRINCIPAL DISPLAY PANEL

BEEKLEY
Sarene™
SOOTHING SKIN STICK
helps prevent and relieve chafing
for skin made sensitive by radiation
dry, non-greasy,
invisible skin lubricant.
no mess, no scent!
balm
NET WT. 1.3 oz (36.9 g)

INGREDIENTS AND APPEARANCE

SARENE SOOTHING SKIN 
allantoin stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52319-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
TRIBEHENIN (UNII: 8OC9U7TQZ0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52319-001-13	1 in 1 BOX
1		36.9 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	04/19/2010

Labeler - Beekley Corporation (001157841)