SHA-LEM- palmitic acid, stearic acid, oleic acid, bismuth subcarbonate, boric acid ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PALMITIC ACID (UNII: 2V16EO95H1) (PALMITIC ACID - UNII:2V16EO95H1), STEARIC ACID (UNII: 4ELV7Z65AP) (STEARIC ACID - UNII:4ELV7Z65AP), OLEIC ACID (UNII: 2UMI9U37CP) (OLEIC ACID - UNII:2UMI9U37CP), BISMUTH SUBCARBONATE (UNII: M41L2IN55T) (BISMUTH CATION - UNII:ZS9CD1I8YE), BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4)

Available from:

Shalem Products, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant Helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips. Temporary protection of minor cuts, scrapes, burns and sunburn. Use on most forms of skin irritations, rashes, non-poisonous insect bites.

Authorization status:

unapproved drug other

Summary of Product characteristics

SHA-LEM- PALMITIC ACID, STEARIC ACID, OLEIC ACID, BISMUTH
SUBCARBONATE, BORIC ACID OINTMENT
SHALEM PRODUCTS, INC.
_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._
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SHA'-LEM OINTMENT
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Palmitic Acid, Stearic Acid, Oleic Acid, Bismuth Subcarbonate, Boric
Acid
_PURPOSE_
Skin Protectant
KEEP OUT OF REACH OF CHILDREN
_USES_
Helps prevent and temporarily protects chafed, chapped, cracked or
wind burned skin and lips.
Temporary protection of minor cuts, scrapes, burns and sunburn. Use on
most forms of skin irritations,
rashes, non-poisonous insect bites.
_WARNINGS_
Skin Protectant For External Use Only
DIRECTIONS: Apply liberally as often as needed. If condition worsens
or does not improve within
seven days, consult a doctor
_INACTIVE INGREDIENT_
White wax
TO ORDER CALL TOLL FREE: 1-877-741-1682
SHALEM PRODUCTS, INC., ANGORA, MN 55703
Reg. U.S. Patent Off.
PACKAGING
TM
SHA-LEM
palmitic acid, stearic acid, oleic acid, bismuth subcarbonate, boric
acid ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:59 8 6 2-10 0
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PALMITIC ACID (UNII: 2V16 EO9 5H1) (PALMITIC ACID - UNII:2V16 EO9 5H1)
PALMITIC ACID
7.25 g in 30 mL
STEARIC ACID (UNII: 4ELV7Z6 5AP) (STEARIC ACID - UNII:4ELV7Z6 5AP)
STEARIC ACID
7.25 g in 30 mL
O LEIC ACID (UNII: 2UMI9 U37CP) (OLEIC ACID - UNII:2UMI9 U37CP)
OLEIC ACID
14.5 g in 30 mL
BISMUTH SUBCARBO NATE (UNII: M41L2IN55T) (BISMUTH CATION -
UNII:ZS9 CD1I8 YE)
BISMUTH
SUBCARBONATE
1.8 9 g
in 30 mL
BO RIC ACID (UNII: R57ZHV8 5D4) (BORIC ACID - UNII:R57ZHV8 5D4)
BORIC ACID
0 .9 5 g
in 30 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WHITE WAX (UNII: 7G1J5DA9 7F)
PRODUCT CHARACTERISTICS
COLOR
ye llo w
S CORE
S HAP E
S IZ E
FLAVOR
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTIO